Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Testicular Neoplasms

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Germ Cells Tumors

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Bevacizumab

Carboplatin

Antibodies

Antibodies, Monoclonal

Etoposide

Melphalan

Ifosfamide

Etoposide phosphate

Immunoglobulins

Isophosphamide mustard

Mesna

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC

Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)

HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC

1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2.

Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5.

50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2.

Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2.

Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3.

3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.

3,000 mg/m\^2 IV over 6 hours on Days -6 to -3

200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4.

Stem Cell Transplant

Yago Nieto, MD, PHD

The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.

This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.

Up to 67 patients will be enrolled in this study.

The Study Drugs:

Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die.

Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.

Study Drug Administration:

You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart.

Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores.

On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours.

On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours.

On Day 6, you will not receive any study drugs.

On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal.

As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine.

Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy.

On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours.

On Days 5-6, you will not receive any study drugs.

On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.

Study Visits:

About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed:

* To check the status of the disease, you will have CT scans of your chest, abdomen, and pelvis.
* Blood (about 3 tablespoons) will be drawn for routine tests.

Length of Study:

You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects.

Long-Term Follow-up:

If your doctor thinks it is needed, you may have follow-up visits.

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.

M.D. Anderson Cancer Center

Nervous System Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Tics

Tic Disorders

Topotecan

Topoisomerase I Inhibitors

AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days \[for patients \> 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days\]

Robert J. Wells, MD

Primary Objectives:

* To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.
* To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors.

Secondary Objectives:

* To evaluate the duration of neutropenia (ANC\<500/micro L) and thrombocytopenia (PLT 50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA in children and young adults with solid tumors.
* To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg, CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.
* To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent apheresis for PBMC collection in courses 2 or 3.

All of the chemotherapy drugs used in this study are FDA approved and commercially available drugs designed to kill cancer cells.

Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will have electrocardiogram (ECG - test to measure the electrical activity of the heart). You will have a chest x-ray and other scans (such as CT, MRI, Bone, Ultrasound or radionucleotide scans ). You physician will decide which scans are appropriate based on the disease and clinical situation. You will also have a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative pregnancy test before starting treatment.

If you are found to be eligible to take part in this study, you will be assigned to a specific dose of topotecan. The first group of participants will receive a smaller dose of topotecan. If patients in that group are able to recover a sufficient number of platelets by Day 22 and no severe side effects are experienced, the next group of participants will be treated with a larger dose topotecan. The dose will continue to be increased for each new group of participants until all the participants in a dose group are unable to recover a sufficient number of platelets by Day 22, or until severe side effects are experienced. There will be 3 patients in each group. The doses of all the other drugs used on this study will be the same for every participants.

Topotecan, ifosfamide, and carboplatin will be given for the first three days of each course. Ifosfamide and carboplatin will be given into a vein for one hour each day along with the drug mesna. Mesna is not an anti-cancer drug but a drug to help protect the bladder from the potential damaging effects of ifosfamide. After the first dose of mesna, participants will receive 3 more doses (one every three hours) over 15-30 minutes . Topotecan is given directly into a vein for one-half hour beginning one hour after treatment with ifosfamide, carboplatin, and the first dose of mesna is completed. Participants who are 22 years or older will only receive Day 1 and 2 of carboplatin.

Starting on the fourth day of each course, you will be given a daily injection of the drug Filgrastim. Filgrastim is a growth factor naturally produced in the body to stimulate the production of white blood cells (infection fighting cells). Filgrastim can now be produced in the laboratory and given to patients at higher doses than the body makes. Filgrastim should help the body recover from treatment. Filgrastim will be given as an injection under the skin once a day until an acceptable number of white blood cells are detected in the bloodstream.

A second course of chemotherapy will begin as soon as 21 days after the start of treatment as long as you have recovered enough white blood cells and platelets. If the white blood cells and platelets have not recovered by 21 days, you will begin the next course when they do recover.

After each of the first three courses, you will have a re-evaluation of the disease. Re-evaluation will require the same scans to be performed as were done at study entry. If the tumor shows a complete or partial response to the treatment after the second course, then continuation on the study will be at the discretion of the treating physician. If the disease is stable, meaning there is no change in the size or degree of the tumor, then treatment can continue for a total of 3 courses overall.

If the disease gets worse or intolerable side effects occur, you will be taken off study and other treatment options will be discussed with you.

You may need to be hospitalized during the first three days of each chemotherapy course and will require visits as an outpatient at other times during treatment to receive laboratory follow-up and evaluation. Participants may also require hospitalization because of side effects.

During treatment, you will have a physical exam and routine blood (about 2 teaspoons) and urine tests. You will also have an ECG, a chest x-ray, and other scans as thought necessary. The physical exam will be done once a week for Courses 1 - 3. The blood tests will be done on Days 1, 3, 5; then twice weekly and on Day 22 of each course. Urine tests will be done on Day 1 of each course and at the end of Course 2. The scans and ECG will be performed at the end of each course or sooner if it is suspected that the disease has gotten worse.

This is an investigational study. The drugs on this study are FDA approved and commercially available. However, their use together in this study is experimental. Up to 78 patients will take part in this study. About 15 patients will be enrolled at UTMDACC.

Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors

A Phase I Study of a Novel Chemotherapeutic Regimen: Topotecan, Ifosfamide and Carboplatin (TIC) in Children and Young Adults With Solid Tumors-- A Limited Multi-Institution Study

Blood and Lymph Conditions

Thrombocytopenia

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin - Ifosfamide (AI) regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

10 mcg/kg AMG 531 + Pre/Pre/Post/Post Chemotherapy Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Beginning with Cycle 2, administered in one of two schedules, either on day after chemotherapy and 2 days later (study cycle) or on day -5 (pre dose) and on day after chemotherapy (post dose) or combination of pre/post days of 21-28 day treatment cycle. Combination if Optimal biological dose (OBD) not reached, additional treatment at 10 mcg/kg dose level, with AMG 531 administered on day -5 (pre dose) and on day after chemotherapy (post dose).

1, 3, or 10 mcg/kg given as injection under the skin (subcutaneous)

AMG 531

AUC=11; Cycle 1 chemotherapy alone then 3 weeks later, in Cycle 2, same dose of chemotherapy followed by AMG 531.

Adriamycin

10 gm/m\^2 IV; OR, High dose ifosfamide = 14 gm/m\^2.

Saroj Vadhan-Raj, MD

The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim).

Primary Objectives:

1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy

Secondary Objective:

1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy

Platelets are cells that help make the blood clot. A decrease in platelets can cause bleeding, which may prevent or delay a patient from receiving chemotherapy. Researchers want to find out if AMG 531 can lower the risk and severity of this side effect. AMG 531 is a protein that stimulates platelet production.

If you are eligible to take part in this study, you will be assigned to 1 of 6 dosing schedules of study drug. The dose of AMG 531 that you receive will depend on when you are enrolled.

In Cycle 1, all patients will receive chemotherapy by itself. Three (3) weeks later, in Cycle 2, the same dose of chemotherapy will be given followed by AMG 531. AMG 531 will be given on one of 3 schedules. AMG 531 will be given as an injection under the skin on the day after chemotherapy and 2 days later; it will be given 5 days before and the day after chemotherapy; or it will be given 5 and 3 days before chemotherapy and on the day after chemotherapy and 2 days later. The schedule you receive will depend on when you enroll on the study. After 2 cycles of treatment, based on response of the disease and tolerance to the treatment, all participants may be able to receive up to 4 more cycles of chemotherapy followed by AMG 531. All participants will continue on the same schedule you were receiving before. The dose of AMG 531 may be increased at one time point during the study based on the response of the platelet counts.

The number of blood tests drawn (about 3 teaspoons each) will depend on your clinical condition. These samples will be taken at least 2 times a week and as often as once a day during portions of the study. You will also have blood (about 1 teaspoon) collected for the evaluation of anti-AMG 531 antibody status before treatment starts, at the end of Cycles 2 and 4, and at the end of study.

You will be taken off the study if your disease gets worse or intolerable side effects occur. At the end of the study, you will have a medical history and physical exam, including measurement of vital signs. You will also have blood (about 1 teaspoon) drawn for routine tests.

This is an investigational study. AMG 531 is not FDA approved or commercially available. At this time, it is being used for research purposes only. Up to 56 patients will take part in this study. All will be enrolled at University of Texas (UT)MD Anderson.

AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Phase I/II Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin

Number of participants experiencing an adverse event (AE) or serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study.

Number of participants experiencing an venous thromboembolism (VTE) related serious adverse event (SAE) during study treatment, possible or probable related to study drug. All toxicities graded using the Common Terminology Criteria for Adverse Events version 3.0. Participation has a maximum of 6 cycles of chemotherapy on the study. VTE events reported are part or whole total number reported for study SAEs, not in addition to SAEs reported.

Amgen

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

1 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

3 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later

10 mcg/kg AMG 531 Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy

10 mcg/kg Pre/Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)

5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy

Cycle 1: Chemotherapy

Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)

10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by AMG 531 subcutaneously of 21-28 day treatment cycle. There were 51 participants who received at least one dose of the study drug.

Dr. Saroj Vadhan-Raj

Adverse Events, Possible or Probable

Serious Adverse Events, Possible or Probable

Total Adverse Events

All participants who received treatment were evaluable for toxicity; therefore 51 participants who received at least one dose of the study drug were evaluable for toxicity.

Number of Participants With Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

Pulmonary Embolism (PE)

Deep Vein Thrombosis (DVT)

Total VTE Related SAEs

Number of Participants With Venous Thromboembolism (VTE) Related Serious Adverse Events in Sequential Cohort Dose Escalation Study of AMG 531 Following Chemotherapy

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. Adriamycin /Ifosfamide (AI) regimens \[Adriamycin (Doxorubicin) 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2

Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.

Chemotherapy :

1. Carboplatin \[area under the concentration curve (AUC) = 11\]; or
2. AI regimen \[Adriamycin 75-90 mg/m\^2 intravenous (IV), Ifosfamide 10-14 gm/m\^2 IV\]; or
3. High dose Ifosfamide: 14 gm/m\^2.

Overall Study

Immune System Diseases

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles.

DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days.

Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.

Radiation Therapy

40 mg by vein Days 1-3 in a 21 day cycle.

67 mg/m2 by vein on Days 1-3 of a 21 day cycle.

1 g/m2 by vein on Days 1-3 of a 21 day cycle.

0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump.

200 mg/m2 by vein on Day 1 of a 21 day cycle.

Bouthaina Dabaja, MD

The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied.

This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Radiation Therapy:

You will receive radiation therapy 5 days a week for 28 to 30 treatments (up to 6 weeks). You will receive a separate consent form that will describe this treatment and its risks in more detail.

Study Visits During Radiation Therapy:

Every week during radiation therapy:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.

Chemotherapy Administration:

You will start Cycle 1 of chemotherapy during your first week of radiation. Each cycle will be 21-days long (or longer if it takes longer for your blood cell counts to recover). You will receive up to 3 cycles of chemotherapy.

On Days 1-3 of each cycle:

* You will receive dexamethasone by vein over about 15 minutes.
* You will receive etoposide by vein over 2 hours.
* You will receive ifosfamide by vein over 3 hours.
* Mesna is given to protect the bladder from side effects. You will receive mesna by vein as a non-stop infusion over 24 hours on Days 1-3 of each cycle.
* On Day 1 only, you will receive carboplatin by vein over 30 minutes.

Study Visits During Chemotherapy:

On or before Day 1, on Day 15 of Cycle 2, and on Day 15 of Cycle 3, blood (about 2 teaspoons) will be drawn for routine tests. You may also have an EKG, if the doctor thinks it is needed.

On or before Day 1 of Cycle 3:

* You will have an EKG, if the doctor thinks it is needed.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive radiation and up to 3 cycles of chemotherapy. You will no longer be able to receive chemotherapy if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over after the end-of-study and follow-up visits.

Follow-Up Visits:

You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be performed:

* Blood (about 2 teaspoons) will be drawn for routine tests.
* Any skin lesions that you may have that are related to the tumor will be measured and photographed.

If your doctor thinks it is needed, your MRI and PET/CT scans will be performed more or less often.

If you leave the study early:

* You will have CT, MRI, and PET/CT scans to check the status of the disease.
* Any skin lesions that you may have that are related to the tumor will be measured and photographed.
* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma

Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma

Progression defined as progressive disease or death due to disease. The evaluation of PFS will include all participants who receive radiation, regardless of whether they receive chemotherapy. Progression free survival measured from protocol entry.

Carcinoma

Carcinoma, Squamous Cell

Penile Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms, Squamous Cell

Penile Diseases

Penile Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Cisplatin 25 mg/m\^2 IV Days 1-3; Ifosfamide 1200 mg/m\^2 IV Days 1-3; Paclitaxel 175 mg/m\^2 IV Day 1

1200 mg/m\^2 By Vein Over 2 Hours on Days 1-3

175 mg/m\^2 By Vein Over 3 Hours on Day 1

Paclitaxel (Taxol)

25 mg/m\^2 By Vein Over 2 Hours on Days 1-3

Lance Pagliaro, MD

Primary Objective:

-To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell carcinoma of the penis.

Before treatment starts, participants will have a complete exam, including blood and urine tests. A CT scan of the abdomen and pelvis will be done. Participants will have a chest x-ray, bone scan, and an EKG (heart test). A special heart function test may also need to be done in some participants. If necessary a biopsy of enlarged lymph node(s) will be obtained prior to treatment.

Blood tests will be repeated once a week during treatment. CT scans of the abdomen and pelvis and a Chest x-ray will be done after 2 treatments with Taxol, Ifosfamide, and Cisplatin. These will also be done before surgery.

The drugs Taxol, Ifosfamide and Cisplatin will be given through a catheter (plastic tube) placed in a vein in the arm or under the collarbone. Taxol will be given over 3 hours the first day of the treatment cycle. To prevent an allergic reaction, before the Taxol is given, the participant will receive three drugs. These are Dexamethasone, Diphenhydramine, and either Cimetidine or Ranitidine.

After Taxol, Ifosfamide will be given over 2 hours every day for the first three days of the treatment cycle. To prevent possible irritation of Ifosfamide to the bladder, participants will also receive Mesna through the plastic catheter. Mesna will be given both before and after Ifosfamide every day. Mesna is not chemotherapy. It is a medication to prevent side effects of Ifosfamide into the bladder.

Every day for the first three days of the cycle, and after Ifosfamide is given, participants will also receive Cisplatin through the catheter at a steady rate over 2 hours, along with Mannitol and salt water to flush the kidneys. This treatment will be given in the hospital and will require staying in the hospital for 3-4 days. It will be repeated for a total of 4 times; once every 21 days, if the participant has high enough numbers of white blood cells and platelets.

Participants may be given injections of G-CSF under the skin once a day for up to 7 days (days 6-12 of the cycle) to bring the white cells up faster after the chemotherapy. This will also lower the risk of severe infections.

After completing 4 treatments of chemotherapy, participants will have blood and urine tests, a chest x-ray to learn the response of the tumor to the chemotherapy. They will also have a CT scan of the abdomen and pelvis. Participants who have a response to the chemotherapy, or show no sign of new spread of the cancer to other parts of the body, will then have surgery. Surgery will be done to remove the tumor. The lymph nodes in the groin will be removed. The pelvic lymph nodes may also need to be removed. How much tissue is removed depends on how far the tumor has spread. The surgeons will explain the specifics of the surgery in a separate consent form.

After completion of the treatment, physical exams, CT scans, chest x-rays, blood tests, and urine tests will be done every 3 months for 2 years. They will then be done every 6 months. These procedures can be done by a physician at M. D. Anderson or by the participant's own doctor. If the participant's doctor does it, the information will need to be forwarded to the doctors at M. D. Anderson. Participants will be expected to come to M. D. Anderson or to their respective participating urologist/medical oncologist at least once every 6 months for a check-up.

This is an investigational study. The FDA has approved Taxol, Ifosfamide, Cisplatin, and Mesna. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.

Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis

A Phase II Study of (Neoadjuvant Chemotherapy Trial Prior to Extirpative Surgery) for Clinical Stage TanyN2-3M0 Squamous Cell Carcinoma of the Penis

Histopathologic assessment of surgical resection to confirm Pathologoic Complete Remission. Complete remission defined as disappearance of all target lesions.

Cisplatin + Ifosfamide + Paclitaxel

Age Continuous

Cherie A. Perez

Participants who completed chemotherapy without progression then had surgical resection.

Number of Participants With Pathologic Complete Remission (pCR)

Lymphoma, Non-Hodgkin

Lenograstim

Ofatumumab

Adjuvants, Immunologic

Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide). After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose. G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

1000 mg by vein on Day 1 and 2000 mg by vein on Day 8

3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.

150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.

2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)

2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)

After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose.

6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.

G-CSF

Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Stem Cell Collection

Issa F. Khouri, MD,BS

The goal of this clinical research study is to learn if it is possible to collect stem cells after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects, number of stem cells collected, and the number of procedures that are needed to collect enough stem cells.

The Study Drugs:

Ofatumumab is a human monoclonal antibody for the CD20 protein designed to bind to the surface of some of the white blood cells (B-cells). It can destroy cancer cells that come from B-cells, and can be used to treat cancers of B-cells such as resistant CLL (chronic lymphocytic leukemia).

Etoposide is designed to slow or stop the growth of cancer cells.

Filgrastim promotes the growth of white blood cells, which help to fight infections.

Ifosfamide is designed to slow or stop the growth of cancer cells.

Mesna is a drug that protects bladder cells from damage by the chemotherapy drug ifosfamide. It is used to decrease the risk of bleeding in the bladder.

Treatment Administration:

You will be admitted to the hospital. You will have to stay in the hospital for 4-6 days for this part of the treatment.

On Day 1, you will receive ofatumumab through the CVL over 6-8 hours.

On Days 2, 3, and 4, you will receive ifosfamide and mesna continuously and etoposide every 12 hours. Mesna is given to help decrease the risk of developing side effects.

As an outpatient, you will receive a higher dose of ofatumumab (about 1 week after the first one) through the CVL over 10-12 hours.

Beginning on Day 6, you will get G-CSF (filgrastim) injections (given under the skin) and will continue to be given until enough stem cells have been collected.

Tests and Procedures:

Every day while you are in the hospital, you will have a physical exam and you will be asked about any side effects you may be having. After you are no longer in the hospital, you will have a physical exam and you will be asked about any side effects you may be having when the doctor thinks it is needed.

While you are waiting for enough stem cells to be collected, you will have blood drawn (about 1 tablespoon) for routine tests at least 3 times a week. If your doctor thinks it is needed, you may have blood drawn more often.

Stem Cell Collection:

Blood stem cells will be collected when your blood counts have returned to normal (about 10-16 days after chemotherapy). The process of stem cell collection takes about 4 hours each time. You will have stem cells collected each day until enough are collected (between 1-6 sessions). A machine is attached to the CVL and blood is withdrawn. The blood then flows through the machine, which removes stem cells from the blood. The blood is then returned back to you through the CVL. The stem cells are then frozen and stored. These stem cells will be given back to you after the next phase of treatment to help your blood counts recover after high dose chemotherapy. After enough stem cells have been collected, you will be admitted to the hospital for high dose chemotherapy. You will sign a separate consent before you receive high dose chemotherapy.

During the stem cell collection, blood (about 2 teaspoons) will be drawn through the CVL to check for cell markers that can affect the response of the cell counts and to check the status of the disease.

Length of Study:

Patients will be followed for up to 12 months after the transplant. You will be taken off study early if the stem cell collection does not work.

This is an investigational study. Etoposide and ifosfamide are FDA approved and are commercially available for lymphomas. Ofatumumab has been approved by the FDA for treatment of recurrent refractory chronic lymphocytic leukemias. G-CSF and Mesna are FDA approved and commercially available. The use of Ofatumumab for the collection of stem cells is investigational.

Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors	NCT00936936	Testicular Canc...	Gemcitabine Docetaxel Melphalan Carboplatin Mesna Ifosfamide Etoposide Stem Cell Trans...	12 Years - 65 Years	M.D. Anderson Cancer Center
Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors	NCT00502892	Solid Tumors	Topotecan Ifosfamide Carboplatin	- 45 Years	M.D. Anderson Cancer Center
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma	NCT02106988	Lymphoma	Radiation Thera... Dexamethasone Etoposide phosp... Ifosfamide Mesna Carboplatin	18 Years -	M.D. Anderson Cancer Center
Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors	NCT00502892	Solid Tumors	Topotecan Ifosfamide Carboplatin	- 45 Years	M.D. Anderson Cancer Center
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors	NCT00936936	Testicular Canc...	Gemcitabine Docetaxel Melphalan Carboplatin Mesna Ifosfamide Etoposide Stem Cell Trans...	12 Years - 65 Years	M.D. Anderson Cancer Center
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	NCT00147225	Solid Tumors Advanced Cancer	AMG 531 Carboplatin Adriamycin Ifosfamide	18 Years -	M.D. Anderson Cancer Center
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis	NCT00512096	Penile Cancer	Ifosfamide Paclitaxel (Tax... Cisplatin	14 Years -	M.D. Anderson Cancer Center
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis	NCT00512096	Penile Cancer	Ifosfamide Paclitaxel (Tax... Cisplatin	14 Years -	M.D. Anderson Cancer Center
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas	NCT01329900	Lymphoma	Ofatumumab Ifosfamide Etoposide Mesna G-CSF Stem Cell Colle...	18 Years - 70 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ifex

Every month we try and update this database with for ifex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ifex

Every month we try and update this database with for ifex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ifex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.