What side effects are associated with this type of intervention?

High-dose combination chemotherapy for Choriocarcinoma, involving drugs like paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, can cause severe nausea, vomiting, hair loss, fatigue, increased infection risk, anemia, and thrombocytopenia. It may also lead to organ toxicity affecting the kidneys, liver, and heart. Stem cell transplant, used to restore blood-forming cells, carries risks such as graft-versus-host disease, infections, and procedural complications.

What prior FDA approvals exist?

Choriocarcinoma, a highly malignant form of gestational trophoblastic disease, has been treated with various chemotherapeutic agents. While specific FDA approvals for high-dose chemotherapy and stem cell transplant in Choriocarcinoma are not detailed, similar aggressive treatments have been studied in other cancers. For instance, high-dose chemotherapy regimens often include drugs like paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, which work by killing rapidly dividing cancer cells. Stem cell transplants are used to restore blood-forming cells destroyed by these high-dose treatments. These approaches are similar to those being studied in trials for other refractory or relapsed cancers, aiming to improve outcomes by aggressively targeting cancer cells and supporting recovery with stem cell transplants.

What other types of research exist?

Promising novel alternatives to high-dose combination chemotherapy and stem cell transplant for choriocarcinoma patients include targeted therapies such as tyrosine kinase inhibitors (e.g., sunitinib, sorafenib) and immunotherapies like immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab). These treatments have shown efficacy in various cancers and may offer a less toxic and more targeted approach for choriocarcinoma patients.

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Platinum-containing Compound

Chemotherapy and Stem Cell Transplant for Germ Cell Cancer

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy may cause nausea, hair loss, fatigue; risk of infection due to low blood counts; kidney damage; nerve problems like numbness or tingling; hearing issues due to cisplatin. Stem cell transplant includes risks of graft failure and serious infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: TI-CEExperimental Treatment7 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: TIPExperimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

carboplatin

2010

Completed Phase 3

~4790

paclitaxel

1996

Completed Phase 3

~4310

ifosfamide

1999

Completed Phase 3

~2230

cisplatin

1997

Completed Phase 3

~3290

etoposide phosphate

2009

Completed Phase 3

~1630

G-CSF

2014

Completed Phase 4

~1610

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Choriocarcinoma involve chemotherapy and stem cell transplant. Chemotherapy drugs such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide target and kill rapidly dividing cancer cells by disrupting cell division and DNA replication. High-dose chemotherapy is particularly aggressive, aiming to eliminate a larger number of cancer cells but also causing significant damage to healthy cells, especially in the bone marrow. Stem cell transplant is then used to restore the blood-forming cells destroyed by the high-dose chemotherapy, enabling the patient to recover bone marrow function and produce healthy blood cells. This approach is vital for Choriocarcinoma patients as it enhances the likelihood of completely eradicating the cancer while managing the severe side effects associated with intensive chemotherapy.