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

Immune System Diseases

Autoimmune Diseases

Infertility

Infertility, Male

Stem cell transplantation Testicular tissue grafting

Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.

Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting

Rachel Neelley

Kyle E Orwig, PhD

Spermatogonial stem cell transplantation through ultrasound guided rete testis injection and testicular tissue grafting will be performed for participants who have frozen testicular tissue prior to gonadotoxic therapy. The purpose of this study is to test the safety and feasibility of these transplant technologies and restore fertility for these participants.

Azoospermia (no sperm in ejaculated semen) impacts 1% of men in the general population and 15% of infertile men, which translates to 645,000 males between the ages of 20 and 50 (prime reproductive years) in the United States. Spermatogenesis arises from a population of spermatogonial stem cells in the testes that maintain continuous sperm production throughout a man's post-pubertal life. Diseases or medical treatments that compromise the stem cell pool and/or prevent the stem cells from differentiating can cause infertility. Adult men have the option to cryopreserve a semen sample prior to therapy but this is not an option for prepubertal patients who are not yet producing sperm. This study will test the safety and feasibility of two approaches to restore sperm production using previously cryopreserved testicular tissues, which contain spermatogonial stem cells.

The first approach is autologous transplantation of testicular cells, including spermatogonial stem cells, into the testis using ultrasound-guided rete testis injection. The second approach is autologous grafting of intact pieces of testicular tissue under the skin in the scrotum.

Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting

The investigators will publish individual participant data, after deidentification. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

Rate of participants where sperm was found in semen analysis or testicular tissue analysis

Rate of participants diagnosed with cancer recurrence

Rate of infection, hospital readmission, re-operation occurs

University of Pittsburgh

Professor

Testicular biopsy is performed to obtain testicular tissue for cryopreservation

Testicular biopsy

Kyle Orwig, PhD

Testicular tissue cryopreservation is an experimental procedure where a young boy's testicular tissue is retrieved and frozen. This technique is reserved for young male patients who are not yet producing mature sperm, with the ultimate goal that their tissue may be used in the future to restore fertility when experimental techniques emerge from the research pipeline.

Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Semen cryopreservation is an established fertility preserving therapy, but is not accessible or appropriate for all men. Currently there are no therapies to preserve the future fertility of preadolescent boys. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means of fertility preservation.

This study will harvest testicular tissue from eligible patients. Separate portions of the harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and maintained for participating patients as a resource for future elective procedures to attempt fertility restoration.

Testicular Tissue Cryopreservation for Fertility Preservation

Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens

The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.

A segment of testicular specimen (\~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining

Children's National Research Institute

Children's Hospital of Orange County

Children's Hospital Medical Center, Cincinnati

Ann & Robert H Lurie Children's Hospital of Chicago

Medical College of Wisconsin

Connecticut Children's Medical Center

Nationwide Children's Hospital

Washington University School of Medicine

Alfred I. duPont Hospital for Children

University of Miami

University of Chicago

Cook Children's Medical Center

Helen DeVos Children's Hospital

Seattle Children's Hospital

University of Texas

Oregon Health and Science University

Hackensack Meridian Health

Indiana University Health

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

Sunitinib Malate

Lance Pagliaro, MD, BA

The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.

The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

Within 14 days of enrollment on this study, you will have the following tests and procedures performed:

* Your complete medical history will be recorded.
* You will have a physical exam.

Within 7 days of enrollment on this study, you will have the following tests and procedures performed:

-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for certain biomarkers (to check the status of the disease).

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take sunitinib malate capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug. These 6 weeks are considered 1 cycle of study treatment.

Study Visits:

On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before you take the study drug:

* You will have a physical exam.
* You will be asked about how you are feeling and about any side effects you have experienced since your last visit.
* You will have blood (about 3 teaspoons) and urine collected for routine tests and to test for certain biomarkers.

For the first 4 weeks of treatment, you should have your blood pressure monitored. This may be done at your home with a digital pressure device, or you may visit your local doctor for this testing.

About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine tests. This may be done at your local doctor's office and results faxed to the study doctor.

On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5, Cycle 7, and so on), you will have imaging scans to check status of the disease. This could include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary, you may have additional imaging scans at any time.

On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram or MUGA scan.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur or if the disease gets worse. However, if the disease gets worse very quickly during Cycles 1 or 2, you will be taken off study at that time.

Off-Study Visit:

When you are taken off of treatment on this study, the following tests and procedures will be performed:

* You will have a physical exam.
* You will be asked how you are feeling and about any changes in your medical history since beginning this study.
* You will also be asked about any side effects you have experienced since your last visit.

This is an investigational study. Sunitinib malate is approved by the FDA for the treatment of adults with kidney cancer. Its use in patients with germ cell tumors is investigational. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.

Sunitinib Malate in Refractory Germ Cell Tumors

Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

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
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh
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
Spermatogonial Stem Cell (SSC) Transplant and Testicular Tissue Grafting	NCT04452305	Infertility, Ma... Cancer Autoimmune Diso...	Spermatogonial ...	-	University of Pittsburgh
Testicular Tissue Cryopreservation for Fertility Preservation	NCT02972801	Cancer Autoimmune Diso...	Testicular biop...	-	University of Pittsburgh
Sunitinib Malate in Refractory Germ Cell Tumors	NCT00912912	Genitourinary D...	Sunitinib Malat...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for testis

Every month we try and update this database with for testis 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 testis

Every month we try and update this database with for testis 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 testis 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.