Chemotherapy and Stem Cell Transplant for Germ Cell Cancer

Not currently recruiting at 135 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two chemotherapy approaches to determine which better treats germ cell tumors that have recurred or not responded to treatment. One group receives a standard-dose combination of chemotherapy drugs, while the other receives a high-dose combination with a stem cell transplant (also known as a bone marrow transplant or hematopoietic stem cell transplantation). The trial seeks males previously treated with specific chemotherapy drugs for germ cell tumors who still have recurring or resistant tumors. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the TIP regimen, which includes paclitaxel, ifosfamide, and cisplatin, effectively treats germ cell tumors. These studies indicate that TIP is generally well-tolerated, though it can cause side effects common to chemotherapy. Patients may experience nausea, tiredness, or low blood cell counts, increasing the risk of infection.

For the TI-CE regimen, involving high-dose chemotherapy and a stem cell transplant, research shows it can be very effective against recurrent tumors. However, it may cause more intense side effects due to higher doses. Common issues include a drop in blood cells, nausea, and a higher risk of infection.

Both treatments aim to stop tumor growth, but they may have different side effects based on their doses and methods. Patients should discuss possible side effects with their doctor to understand what to expect and how to manage them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the chemotherapy and stem cell transplant approach for germ cell cancer because it brings together multiple powerful treatments. Unlike the standard options that typically involve either chemotherapy or transplant alone, this approach combines high-dose chemotherapy agents like ifosfamide and carboplatin with a stem cell transplant to potentially enhance effectiveness and recovery. The use of stem cell reinfusion is particularly promising as it allows patients to receive higher doses of chemotherapy while helping their bodies recover faster. This combination could offer a more robust attack on cancer cells while supporting patient resilience.

What evidence suggests that this trial's treatments could be effective for germ cell cancer?

Research has shown that the TIP treatment plan, which includes paclitaxel, ifosfamide, and cisplatin, is effective as a second option for treating germ cell tumors. Studies have found that 66% of patients do not experience cancer progression for at least five years, and 69% survive beyond five years. In this trial, some participants will receive the TIP regimen.

The TI-CE treatment, another option in this trial, involves high-dose chemotherapy combined with a stem cell transplant. It has proven effective for patients with advanced disease, showing positive results even for those with more severe conditions. Both treatments in this trial offer hope for germ cell tumors that have recurred or are not responding to initial treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Darren Feldman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3651604/

TI-CE High-Dose Chemotherapy for Patients With ... Even with advanced disease, 70% are cured with standard chemotherapy consisting of etoposide and cisplatin with or without bleomycin. Treatment options for the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2059702925009500

Multicenter analysis of high-dose chemotherapy regimens ... Firstly, TICE delivers a higher cumulative dose of carboplatin due to both increased per-cycle dosing and the addition of a third cycle. Secondly, TICE has ...

3. ascopubs.org ascopubs.org/doi/10.1200/jco.2013.31.15_suppl.4534

Phase I/II study of paclitaxel plus ifosfamide (TI) followed by ... Conclusions: Although there was preliminary evidence of efficacy, high dose TI-TIC was associated with acute and chronic renal insufficiency. TI-CE remains the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20194867/

TI-CE high-dose chemotherapy for patients with previously ... Conclusion: TI-CE is effective salvage therapy for GCT patients with poor prognostic features. Mediastinal primary site and two or more lines of ...

5. cincinnatichildrens.org cincinnatichildrens.org/service/c/clinical-trials/studies/A031102

Clinical Trials / Research Studies ... This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell ...

6. astctjournal.org astctjournal.org/article/S1083-8791(05)00459-3/fulltext

Paclitaxel-Based High-Dose Chemotherapy with ... We evaluated the antitumor activity of tandem cycles of high-dose chemotherapy with autologous peripheral stem cell transplantation (aPSCT) in relapsed germ ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02375204

Study Details | NCT02375204 | Standard-Dose ... This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell ...