← Back to Search

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

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
Select...
I have been recently diagnosed with germ cell tumor (GCT).
Select...
My germ cell tumor is not considered low-risk.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I currently have an active infection.
Select...
I am HIV positive and on HAART therapy.
Select...
I have no other cancers except for non-melanoma skin cancer.
Select...
I am not currently receiving any chemotherapy treatments.

Timeline

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

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
~5810
Ifosfamide
2010
Completed Phase 4
~3140
Cisplatin
2013
Completed Phase 3
~2360
Mesna
2003
Completed Phase 2
~1380

Find a Location

Who is running the clinical trial?

University of ChicagoOTHER
1,034 Previous Clinical Trials
753,602 Total Patients Enrolled
Stanford UniversityOTHER
2,448 Previous Clinical Trials
17,492,302 Total Patients Enrolled
University of Texas Southwestern Medical CenterOTHER
1,072 Previous Clinical Trials
1,056,170 Total Patients Enrolled
1 Trials studying Germ Cell Tumors
10 Patients Enrolled for Germ Cell Tumors

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT01873326 — Phase 2
Germ Cell Tumors Research Study Groups: Paclitaxel, Ifosfamide and Cisplatin (TIP), Bleomycin, Etoposide and Cisplatin (BEP)
Germ Cell Tumors Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT01873326 — Phase 2
Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01873326 — Phase 2
~5 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top