Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Topotecan

Bortezomib

Sirolimus

Deoxyglucose

Temsirolimus

MTOR Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Torisel starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle.

Hycamtin starting Dose 0.8 mg/m\^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle.

Velcade starting Dose 0.3 mg/m\^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle.

Torisel + Hycamtin + Velcade Expansion Group

Addition of 10 participants at highest tolerated dose level

Starting Dose 5 mg Intravenously over 30-60 minutes, Days 1, 8, and 15 of 21 Day Cycle

Torisel (Temsirolimus)

Starting Dose 0.8 mg/m\^2 Intravenously over 30-60 minutes on Days 1 and 8 of 21 Day Cycle

Hycamtin (Topotecan)

Starting Dose 0.3 mg/m\^2 Intravenously over 1 minute on Days 1, 4, 8, and 11 of 21 Day Cycle

Velcade (Bortezomib)

Daniel Karp, MD

The goal of this clinical research study is to find the highest tolerable dose of Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.

The Study Drugs:

Temsirolimus is designed to block pathways that control important events such as the growth of blood vessels that are vital for the growth of cancer. This may cause cancer cells to die.

Topotecan hydrochloride is designed to block the function of important proteins in cancer cells. These proteins, when active, allow a cell's genes to duplicate and for the cancer cells to divide.

Bortezomib is designed to block the function of important proteins in cancer cells. These proteins control the destruction of proteins in tumor cells, which is important for their growth. This may cause cancer cells to die.

Study Drug Dose Level:

If you are found to be eligible to take part in this study, you will be enrolled into a group of about 3-6 participants that are receiving the same drug combination. The first group of participants will receive the lowest dose of the drug combination. The next group of participants will receive the next highest dose of the drug combination. The third group will receive an even higher dose than that. This process will continue until the study doctor finds the highest safe dose of the drug combination. The dose that you receive will depend on when you are enrolled in this study and the safety data that is available at that time. The dose that you receive may be lowered if you do not tolerate the study drug combination well. You will not receive any doses of the study drug higher than the dose you are first assigned to.

Once the highest tolerated dose is found, up to 10 more participants will be added at that dose level. This is called an Expansion Group.

Study Drug Administration:

Temsirolimus, topotecan, and bortezomib will be given in "cycles." Cycles will be about 21 days long or longer, depending on any side effects you may experience.

On Days 1, 8, and 15 of each cycle, you will receive temsirolimus through a needle in your vein over about 30-60 minutes.

On Days 1 and 8 of each cycle, you will receive topotecan hydrochloride by vein over about 30-60 minutes.

On Days 1, 4, 8, and 11 of each cycle, you will receive bortezomib by vein over less than 1 minute.

While on study you will not be able to take any drugs that may interfere with the study drugs. You should talk with your doctor before taking any non-study drugs.

Study Visits:

Once a week during Cycle 1, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* If the doctor thinks it is needed, urine will be collected for routine tests.

If you are in the Expansion Group, then during Week 3 of Cycle 1, you will have a tumor biopsy to compare the activity of the tumor before treatment and after treatment has begun. This is done for research purposes only.

If you are in the Expansion Group, then 24-48 hours after starting Week 1 of Cycle 1, you will have a bone marrow aspiration performed. The tissue will be used to see how the study drug combination acts in the body and to learn the effect it may have on cancer cells. This is done for research purposes only.

During Week 1 of Cycle 2, you will have an ECG. After this, you will have extra ECGs if the doctor thinks it is needed.

During Week 1 of Cycles 2 and beyond, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* If the doctor thinks it is needed, urine may be collected for routine tests.

Once every 2 cycles (Cycles 2, 4, 6, and so on), you will have a CT or MRI scan to check the status of the disease.

FDG-PET Scans:

Every 2-3 months while you are on study and before Cycle 1 if you have not had a FDG-PET within the last 1 month, you may have a FDG-PET scan. You must fast for at least 6 hours before the FDG-PET scan. If you are a diabetic, you must fast for at least 4 hours before the FDG-PET scan. If it is needed, you may take drugs or drink water. The FDG-PET will be used to see if the activity of the cancers decreased with the drugs.

You will receive a small amount of FDG solution by vein. You will then rest in a quiet darkened room for 45-60 minutes before the PET scan. Pictures of your body will be taken using a PET scanner, which will about take 1 1/2 hours. The entire procedure should take about 3 hours.

Each time you have a FDG-PET scan, blood (either a finger stick or about 1 teaspoon) will be drawn to measure your blood sugar levels.

Length of Study Participation:

You will be on study for as long as you are benefiting. You will be taken off study if the disease gets worse or intolerable side effects occur.

End-of-Treatment Visit:

After you are off study, you will have an end-of-treatment visit. At this visit, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 2 teaspoons) will be drawn for routine tests.

This is an investigational study. Temsirolimus, topotecan, and bortezomib are all FDA approved and commercially available. Temsirolimus is FDA approved for the treatment of renal cell cancer. Topotecan hydrochloride is FDA approved for the treatment of ovarian, small cell lung, and cervical cancers. Bortezomib is FDA approved for the treatment of multiple myeloma and mantle cell lymphoma. The use of these drugs together is investigational and authorized for use in research only.

Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study of Temsirolimus, Topotecan, and Bortezomib

A Phase I Study of Temsirolimus, Topotecan, and Bortezomib in Patients With Advanced Malignancy

MTD is defined as the highest dose in which the incidence of a dose limiting toxicity (DLT) is \< 33%.

M.D. Anderson Cancer Center

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Nervous System Diseases

Uterine Cervical Neoplasms

Head and Neck Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Velcade (bortezomib)

Adam Dicker, MD, PhD

The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

* To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
* To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
* To evaluate tumor response

A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients

A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients

Millennium Pharmaceuticals, Inc.

Sidney Kimmel Cancer Center at Thomas Jefferson University

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Micronutrients

Vitamins

Ascorbic Acid

Melphalan

Arsenic Trioxide

Trace Elements

Antineoplastic Agents, Alkylating

Alkylating Agents

Antioxidants

Protective Agents

Vitamin C

Arm 1: Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Arm 2: Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Arm 3: Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

0.25 mg/kg by vein over 2 hours, once a day for 7 days (Days -9 to -3).

Trisenox (Arsenic Trioxide)

Arm 1 (Level 1):

1.0 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

Arm 2 (Level 2):

1.5 mg/m\^2 intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

100 mg/m2 by vein days -4,-3, over 30 minutes

1000 mg once a day through the vein for 7 days.

Vitamin C (Ascorbic Acid)

Muzaffar H. Qazilbash, MD

Primary Objectives:

1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
3. To determine the effects of bortezomib on melphalan pharmacokinetics

Melphalan is designed to damage the DNA of cells, which may cause cancer cells to die. High-dose melphalan is considered the standard of care for multiple myeloma. Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die. Arsenic trioxide may cause cancer cells to die, and researchers want to find out if arsenic trioxide helps melphalan in killing cancer cells. Vitamin C makes arsenic trioxide more available inside the cancer cells, and researchers want to learn if Vitamin C makes arsenic trioxide more effective.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will have a dental exam to check for any infected teeth or gums that may flare up after chemotherapy.

You will have a bone marrow aspirate and biopsy. To collect a bone marrow aspirate/biopsy, 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. Cytogenetic tests will be performed on the aspirate sample to look for any genetic abnormalities in your DNA. You will have x-rays of your bones taken. The study doctor will look at the x-rays to see if there are any myeloma-related bone changes. You will also have a chest x-ray.

You will have blood (about 2 tablespoons) and urine collected for routine tests. You will have a pulmonary function test, to check if your lungs are strong enough for high-dose chemotherapy. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will also have a MUGA scan to evaluate the function of your heart. Women who are able to have children must have a negative blood pregnancy test. The blood will be drawn as part of the 2 tablespoons drawn at screening.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of dice) to one of 3 treatment groups. There is an equal chance of being assigned to any of the 3 groups. All 3 groups will receive melphalan, arsenic trioxide, and Vitamin C. The second and third groups will also receive bortezomib, but at different dose levels. The first 3 participants assigned to receive bortezomib on this study will receive the lower of 2 bortezomib dose levels.

You will receive arsenic trioxide through a needle in a vein over 2 hours, once a day for 7 days (Days -9 to -3). At the same time, you will receive Vitamin C once a day through the vein for 7 days. After you receive the arsenic trioxide on Days -4 and -3, you will receive melphalan through the vein over 30 minutes.

If you are in Group 2 or 3, you will receive bortezomib by an intravenous (IV) push on Days -9, -6, and -3. An IV push takes a short period of time (less than 1 minute).

You will receive standard inpatient and outpatient stem cell transplant care and testing. You will have to sign a separate consent form that describes the transplant procedure and its risks. Your stem cells will be reinfused 2 days after the last dose of melphalan. To check for any side effects, you will have an ECG performed 14 days after the transplant.

If intolerable side effects from the chemotherapy occur or there is sign of disease after the transplant, you will be taken off study. If you have already received melphalan and side effects occur, then the transplant will happen. However, if intolerable side effects develop before melphalan, then you may be taken off study without having the transplant. If you are taken off study early, you still may need to return for routine post-transplant follow-up visits, if your transplant physician decides it is necessary.

If there is no sign of disease after the transplant, you will have routine follow-up visits. Blood (about 2 tablespoons) will be drawn for routine tests at least once a week during the first month after the transplant, and then once every month for the next 3 months after that. At about 3, 6, and 12 months after the transplant, you will have bone marrow biopsies and aspirates performed to check the status of the disease. You will have blood (about 2 tablespoons) and urine collected for routine tests. At 12 months after the transplant, you will have x-rays of your bones taken.

One (1) year after the transplant, your participation in this study will be over.

This is an investigational study. Bortezomib, arsenic trioxide, and melphalan are commercially available and FDA-approved for use in patients with myeloma. However, their use in combination with Vitamin C (also commercially available) is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients

Phase I/II Study of the Combination of Bortezomib With Arsenic Trioxide, Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

Number of participants with CR at Day 180 who had maintained CR for at minimum of 4 weeks, and who had: No monoclonal protein in urine/serum when analyzed by immunofixation electrophoresis; bone marrow normal by morphological examination with \<5% plasma cells, \<1% aneuploid light chain restricted population by flow cytometry for DNA/cIg; and, while healing of bony lesion is not required, no new lytic lesion should appear. Further compression fracture of spine not considered progressive disease.

The time to patient toxicity of drug combination bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan defined in days from baseline measure to occurence of adverse events grade 4 (life threatening or disabling) according to National Cancer Institute Common Toxicity Criteria (CTC), version 3.

Cephalon

Melphalan 100 mg/m\^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

No Bortezomib

Bortezomib (Level 1) 1.0 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m\^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Bortezomib 1.0 mg/m^2

Bortezomib (Level 2) 1.5 mg/m\^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily

Bortezomib 1.5 mg/m^2

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Muzaffar H. Qazilbash, MD/Professor, Stem Cell Transplantation

Number of Patients Reaching Complete Response (CR)

Time to Toxicity

Overall Study

Symptoms and General Pathology

Recurrence

Vaginal Neoplasms

Vaginal Diseases

Vaginal Cancer

Irinotecan

Don S Dizon, MD

This study is conducting an evaluation of two chemotherapy drugs, Velcade and Irinotecan, in women with advanced, recurrent, or metastatic cervical cancer, vaginal cancer, or vulvar cancer. Patients with cervical cancer may have received a platinum-containing treatment as systemic therapy without radiation, but is not required.

This is a phase 2 study. Patients with advanced or metastatic histologically documented squamous cell carcinoma, adenocarcinoma, or adenosquamous cancers originating in the cervix, vagina, or vulva will be eligible. Measurable disease by either clinical exam or radiography is also required. Patients receiving cisplatin-based chemoradiation as definitive treatment for local disease will be eligible. Patients must have no more than one prior platinum-based chemotherapy regimen in the metastatic setting. Patients presenting with distant metastatic disease (beyond the pelvis) will be eligible, as long as they are not eligible for a higher priority study.

Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer

A Phase II Study of VELCADE TM(PS-341) and Irinotecan in the Treatment of Progressive, Recurrent or Metastatic Cervical, Vulvar, or Vaginal Cancer

Women and Infants Hospital of Rhode Island

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Dexamethasone

Cyclophosphamide

Lenalidomide

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Angiogenesis Inhibitors

Growth Inhibitors

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide)

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide)

VELCADE (bortezomib), dexamethasone, cyclophosphamide

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide

bortezomib 1.3 mg/m\^2 given via IV on days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on days 1, 8, 15 and 22 of a 6-week cycle for 4 cycles (maintenance).

VELCADE (bortezomib)

dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop

dexamethasone

cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop

cyclophosphamide

lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm)

lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)

Revlimid (lenalidomide)

Medical Monitor

The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.

Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

Phase 1/2 Study of VELCADE® (Bortezomib), Dexamethasone, and Revlimid® (Lenalidomide) Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma

Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.

Very good partial response requires serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h

Evaluate the safety and tolerability of the combination therapy

Overall Response includes complete response and partial response.

Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.

Partial response requires at least 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by at least 90% or to \< 200 mg per 24 hour.

Stringent Complete Response is defined as complete response plus normal free light chain (kappa/lambda) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Complete response requires negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.

Near Complete response requires positive immunofixation on the serum and/or urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.

Duration of response is the time from date of first documented confirmed response to date of first documented progressive disease. A confirmed response is a response that has been observed on at least two consecutive assessments.

Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.

Time to disease progression is defined as time from the date of randomization to the date of first documented progressive disease.

Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.

Time to response is defined as time from date of randomization to the date of the first documentation of a confirmed response. confirmed response is a response that has been observed on at least two consecutive assessments.

Progression-free survival is defined as time from the date of randomization to the date of the first documented progressive disease or death.

Disease progression requires any one or more of the following: serum m-protein increase \>= 25% from nadir(absolute increase \>= 0.5 g/dL); Urine m-protein increase \>= 25% from nadir(absolute increase \>= 200 mg/24 hr), bone marrow plasma cell percentage increase \>= 25% from nadir(absolute increase \>= 10%), new bone lesion or soft tissue plasmacytomas.

Overall survival is defined as time from the date of randomization to the date of death

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

From first dose of any study drug to end of treatment period

VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

V-DR

VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 100 - 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

VDCR

VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

V-DC

Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

VDC-mod

Age, Categorical

Age Continuous

Dixie-Lee Esseltine, MD

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally \[PO\] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop.

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.

Bortezomib: 1.3 mg/m\^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.

Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

Cyclophosphamide: 500 mg/m\^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.

The response-evaluable population is defined as phase 2 patients with measurable disease at baseline and with at least 1 post baseline response assessment.

Number of Patients With Combined Complete Response and Very Good Partial Response

The safety population includes patients received any dose of any study drug.

Number of Patients With Adverse Events (AEs)

Number of Patients With Overall Response

Number of Patients With Stringent Complete Response Rate

Number of Patients With Complete Response Rate + Near Complete Response Rate

Responders (patients achieved complete and partial response) in the response evaluable population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Temsirolimus, Topotecan, and Bortezomib	NCT00770731	Advanced Cancer	Torisel (Temsir... Hycamtin (Topot... Velcade (Bortez...	-	M.D. Anderson Cancer Center
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients	NCT00329589	Brain Cancer Head and Neck C... Cervix Cancer Central Nervous...	Velcade (bortez...	18 Years -	Thomas Jefferson University
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients	NCT00469209	Myeloma	Trisenox (Arsen... Velcade (Bortez... Melphalan Vitamin C (Asco...	- 75 Years	M.D. Anderson Cancer Center
Study of Velcade and Irinotecan in Advanced Cervical, Vulvar, or Vaginal Cancer	NCT00106262	Cervical Cancer	Velcade (bortez... Irinotecan	18 Years - 80 Years	Women and Infants Hospital of Rhode Island
A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients	NCT00329589	Brain Cancer Head and Neck C... Cervix Cancer Central Nervous...	Velcade (bortez...	18 Years -	Thomas Jefferson University
Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients	NCT00507442	Multiple Myelom...	VELCADE (bortez... dexamethasone cyclophosphamid... Revlimid (lenal...	18 Years -	Millennium Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for velcade (bortezomib)