Chemotherapy and Stem Cell Transplant for Germ Cell Cancer

Recruiting at 127 trial locations

Overseen By Darren Feldman, MD

Age: Any Age

Sex: Male

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Cytotoxic drugs, Targeted therapies

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12-15 weeks

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot have concurrent treatment with other cytotoxic drugs or targeted therapies. It's best to discuss your current medications with the trial team to see if they are allowed.

What data supports the effectiveness of the treatment involving chemotherapy and stem cell transplant for germ cell cancer?

Research shows that high-dose chemotherapy with drugs like carboplatin, etoposide, and ifosfamide, combined with stem cell transplants, can help some patients with advanced or relapsed germ cell tumors become disease-free. In one study, 67.6% of patients remained disease-free after treatment, indicating its potential effectiveness. ^{1 2 3 4 5}

Is the chemotherapy and stem cell transplant treatment for germ cell cancer safe?

The treatment involving high-dose carboplatin, etoposide, and ifosfamide with stem cell transplant has shown significant risks, including kidney damage and severe infections, which can be life-threatening. While some patients have achieved remission, the treatment is associated with substantial side effects, including kidney toxicity and the need for dialysis in some cases. ^{3 5 6 7 8}

How is the chemotherapy and stem cell transplant treatment for germ cell cancer different from other treatments?

This treatment is unique because it combines high-dose chemotherapy with a stem cell transplant, which helps the body recover from the intense treatment. It uses drugs like carboplatin and etoposide at higher doses than usual, which can be more effective for patients whose cancer has not responded to standard treatments. ^{2 3 5 9 10}

What is the purpose of this trial?

This study is evaluating whether a combination of chemotherapy and a stem cell transplant is more effective than chemotherapy alone in treating patients with germ cell tumors.

Research Team

Darren Feldman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for male patients aged 14 and above (18+ in Germany) with germ cell tumors that have come back or didn't respond to treatment. They should've had only one prior chemotherapy line, no high-dose chemo before, and be free from other cancers except certain non-aggressive types. Participants need good organ function, no recent treatments that conflict with the study drugs, and can't have fully resectable late relapse tumors.

Inclusion Criteria

My germ cell tumor has grown or returned after one round of chemotherapy.

My cancer has been confirmed as GCT by a pathologist.

I've had 3-6 rounds of initial chemo with cisplatin. Up to 7 if I needed urgent treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-dose chemotherapy (TIP) for 4 cycles or high-dose chemotherapy (TI-CE) for 5 cycles, including stem cell transplant in the TI-CE arm

12-15 weeks

Multiple visits for chemotherapy administration and monitoring

Follow-up

Participants are monitored for safety, effectiveness, and progression-free survival after treatment

12 weeks

Treatment Details

Interventions

• Carboplatin
• Cisplatin
• Etoposide Phosphate
• Ifosfamide
• Stem Cell Transplant

Trial Overview The trial compares standard-dose chemo against high-dose chemo followed by a stem cell transplant in treating refractory/relapsed germ cell tumors. It tests if stopping cancer cells' growth through intense treatment plus stem cell support improves outcomes versus regular doses of paclitaxel, ifosfamide, cisplatin, carboplatin, etoposide phosphate.

Participant Groups

Group I: Arm B: TI-CE Experimental Treatment 7 Interventions

Patients will receive treatment for a total of 5 cycles. Cycles 1-2 (1 cycle = 14 days) * paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 2000 mg/m\^2 IV daily on Days 1-3 with mesna protection as defined in the protocol * G-CSF 10 µg/kg subcutaneously on Days 3-15 (cycle 1) and Days 3-14 (cycle 2) or pegylated G-CSF 6 mg subcutaneous on Day 4 or 6 (cycle 1) and Day 4 or 5 (cycle 2) * leukapheresis every 14 days, if there is an inadequate number of CD34+ cells/kg collected in cycle 1 Cycles 3-5 (1 cycle = 21 days) * carboplatin daily on Days 1-3 * etoposide 400 mg/m\^2 daily on Days 1-3 * stem cell reinfusion on day 5 * pegylated G-CSF 6 mg subcutaneously or G-CSF at approximately 5 µg/kg daily on Days 5-15 Patients may commence with each Arm B cycle provided they meet the criteria as defined in the protocol.

Group II: Arm A: TIP Experimental Treatment 5 Interventions

Patients will receive treatment for 4 cycles administered every 21 days. Cycles 1-4 (1 cycle = 21 days) * paclitaxel 250 mg/m\^2 IV over 24 hours on Day 1 including premedication as defined in the protocol (eg, dexamethasone, diphenhydramine and H2 blocker) * ifosfamide 1500 mg/m\^2 IV daily on Days 2-5 with mesna protection as defined in the protocol * cisplatin 25 mg/m\^2 IV daily on Days 2-5 * pegylated G-CSF 6 mg subcutaneous on Day 6 or 7 or G-CSF as defined in the protocol on Days 6-18 Patients may commence with each Arm A cycle provided they meet the criteria as defined in the protocol.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Institute of Cancer Research (ICR), United Kingdom

Collaborator

Trials

1

Recruited

420+

UNICANCER

Collaborator

Trials

237

Recruited

352,000+

Irish Group CTI

Collaborator

Trials

1

Recruited

420+

European Organisation for Research and Treatment of Cancer - EORTC

Collaborator

Trials

417

Recruited

166,000+

Movember Foundation

Collaborator

Trials

15

Recruited

41,800+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Cancer Research UK

Collaborator

Trials

262

Recruited

4,435,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

An Italian experience of high-dose chemotherapy and autologous bone marrow transplantation (ABMT) in germ cell tumours. Suggestions for future direction. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility and usefulness of high-dose chemotherapy (high-dose ifosfamide, carboplatin and etoposide) combined with peripheral blood stem cell transplantation for male germ cell tumor: a single-institute experience. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Phase I/II Trial of Paclitaxel With Ifosfamide Followed by High-Dose Paclitaxel, Ifosfamide, and Carboplatin (TI-TIC) With Autologous Stem Cell Reinfusion for Salvage Treatment of Germ Cell Tumors. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Role of autologous bone marrow transplantation in germ-cell cancer. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Dose-intensive chemotherapy in refractory germ cell cancer--a phase I/II trial of high-dose carboplatin and etoposide with autologous bone marrow transplantation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Nephrotoxicity after high-dose carboplatin, etoposide and ifosfamide in germ-cell tumors: incidence and implications for hematologic recovery and clinical outcome. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Modified cisplatin, etoposide, and ifosfamide (PEI) salvage therapy for male germ cell tumors: long-term efficacy and safety outcomes. [2020]

8. England pubmed.ncbi.nlm.nih.gov

High dose carboplatin/VP-16 plus ifosfamide with autologous bone marrow support in the treatment of refractory germ cell tumors. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

High-dose carboplatin, etoposide, and cyclophosphamide for patients with refractory germ cell tumors: treatment results and prognostic factors for survival and toxicity. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Germ cell tumors: dose-intensive therapy. [2007]