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Platinum-containing Compound

TIP vs BEP Chemotherapy for Germ Cell Cancer

Phase 2

Waitlist Available

Led By Darren Feldman, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have newly diagnosed GCT

Patients must be classified as having intermediate or poor-risk germ cell tumor

Must not have

Presence of an active infection

Patients known to be HIV positive and receiving HAART

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different combinations of drugs to see which is more effective in treating people with intermediate- and poor-risk germ cell tumors.

Who is the study for?

Adults with intermediate- or poor-risk germ cell tumors who haven't had chemotherapy, except possibly one or two cycles for stage I seminoma. They should have measurable disease and agree to use contraception. Exclusions include pregnant individuals, those unable to follow the protocol, concurrent serious illnesses, other cancers (except non-melanoma skin cancer), HIV patients on HAART therapy, and active infections.

What is being tested?

The trial compares two drug combinations for germ cell tumors: TIP (paclitaxel, ifosfamide, cisplatin) which is experimental; versus BEP (bleomycin, etoposide, cisplatin), the current standard treatment. The goal is to determine which combination is safer and more effective.

What are the potential side effects?

Possible side effects include allergic reactions to drugs; damage to blood cells leading to increased infection risk; kidney problems from high drug levels; lung issues like coughing or difficulty breathing; nausea and vomiting due to stomach irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been recently diagnosed with germ cell tumor (GCT).

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My germ cell tumor is not considered low-risk.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active infection.

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I am HIV positive and on HAART therapy.

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I have no other cancers except for non-melanoma skin cancer.

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I am not currently receiving any chemotherapy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

favorable best response rate

Secondary study objectives

overall best response

overall survival (OS)

progression-free survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Paclitaxel, Ifosfamide and Cisplatin (TIP)Experimental Treatment4 Interventions

Paclitaxel 120 mg/m2 IV over 120-180 min Days 1 and 2 (+/- 4 days)\* Mesna 120 mg/m2 IV (duration of infusion per institutional guidelines) approximately 30 minutes prior to initiation of ifosfamide Days 1-5 (+/- 4 days)\* Ifosfamide 1200 mg/m2 IV over approximately 60 to 120 min Days 1-5 or per institutional guidelines (mixed 1:1 with mesna) (+/- 4 days)\* Mesna\*\* 1200 mg/m2 IV over approximately 60-120 min or per institutional guidelines (mixed 1:1 with ifosfamide)(+/- 4 days)\* Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)\* \*\*Additional mesna may be given at the discretion of the investigator \*Paclitaxel or Ifosfamide or Mesna or Cisplatin or any combination of these agents can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.

Group II: Bleomycin, Etoposide and Cisplatin (BEP)Active Control3 Interventions

Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)\* Etoposide 100 mg/m2 IV over approximately 1 hour Days 1-5 (+/- 4 days)\* Bleomycin 30 U flat dose IV push Days 2, 8 and 15 (all +/- 4 days) \*Etoposide or Cisplatin or both can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Ifosfamide

2010

Completed Phase 4

~3350