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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

favorable best response rate

Secondary outcome measures

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

~5380

Ifosfamide

2010

Completed Phase 4

~2980

Cisplatin

2013

Completed Phase 3

~1940

Mesna

2003

Completed Phase 2

~1380

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoOTHER

1,001 Previous Clinical Trials

817,638 Total Patients Enrolled

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,916 Total Patients Enrolled

University of Texas Southwestern Medical CenterOTHER

1,047 Previous Clinical Trials

1,053,707 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most recent data on Paclitaxel's safety profile?

"While there is some evidence from Phase 2 trials to support the safety of Paclitaxel, more data needs to be collected regarding its efficacy. Therefore, it was given a score of 2."

Answered by AI

In how many different geographical areas is this study being conducted?

"There are a total of 15 sites for this clinical trial, with Memorial Sloan Kettering Nassau in Uniondale, New york, University of Chicago in Chicago, Illinois, and University of Southern California in Los Angeles, California being three of them."

Answered by AI

Is it possible to join this clinical trial at this time?

"This particular clinical trial, as stated on the government-run website, is not looking for any more patients at this time. The study was originally posted on 6/1/2013 and updated last on 7/1/2022. There are, however, 1,731 other studies that are currently enrolling patients."

Answered by AI

Could you please share what other research studies have been done that involved Paclitaxel?

"Paclitaxel was first trialled in 1997 by the City of Hope Comprehensive Cancer Center. Since then, there have been a total of 2346 completed clinical trials worldwide. Out of these studies, 1657 are still active; many of them based out of Uniondale, New york."

Answered by AI

For what sort of treatments is Paclitaxel commonly leveraged?

"Paclitaxel is an effective treatment for merkel cell cancer. Additionally, this medication can be used to treat squamous cell carcinoma, testicular choriocarcinoma, and locally advanced non-small cell lung cancer."

Answered by AI

What is the maximum number of people who can join this clinical trial?

"This particular clinical trial is not enrolling patients at the moment. The listing was first created on June 1st, 2013 and updated as recently as July 1st, 2022. There are 74 trials for germ cell tumors and 1657 studies involving Paclitaxel that are still recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors

2013. "Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01873326.

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