Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Active	18 and over	NCI	MSKCC-06077 NCT00423852

Objectives

1. Determine the safety of paclitaxel and ifosfamide followed by dose-escalated, dose-intensive paclitaxel, carboplatin, and ifosfamide with autologous peripheral blood stem cell support in patients with cisplatin-resistant germ cell tumor. (Phase I)
2. Determine the maximum tolerated dose of paclitaxel, carboplatin, and ifosfamide when given with a high-dose treatment program in these patients. (Phase I)
3. Determine the efficacy of this regimen when given as salvage therapy in the second-line or third-line setting, in terms of complete response, in these patients. (Phase II)

Entry Criteria

Disease Characteristics:

• Histologically confirmed germ cell tumor (GCT)
  • Primary CNS GCT allowed



• Unidimensionally measurable disease OR elevated serum tumor markers (alpha-fetoprotein and/or human chorionic gonadotropin)



• Advanced disease
  • Disease resistant to a cisplatin-based chemotherapy regimen (i.e., failed to achieve a durable complete response to cisplatin)



• Known residual disease after post-chemotherapy surgery allowed

Prior/Concurrent Therapy:

• See Disease Characteristics
• Recovered from recent surgery
• At least 3 weeks since prior chemotherapy
• No prior high-dose therapy with autologous bone marrow transplantation
• No other concurrent chemotherapy
• No other concurrent treatment (e.g., surgery or radiotherapy)

Patient Characteristics:

• Platelet count ≥ 100,000/mm³
• WBC ≥ 3,000/mm³
• Creatinine clearance > 50 mL/min (unless due to tumor obstructing the ureters)
• AST and ALT < 2 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection
• Negative serology for HIV type I and II, human T-lymphotropic virus type I and II, hepatitis B or C virus, syphilis, and cytomegalovirus
• Adequate medical condition for general anesthesia

Expected Enrollment

A total of 68 patients will be accrued for this study.

Outcomes

Response (complete and partial)
Maximum tolerated dose of paclitaxel, carboplatin, and ifosfamide
Efficacy
Safety

Outline

This is a phase I, dose-escalation study of paclitaxel, carboplatin, and ifosfamide followed by a phase II, open-label study.

• Phase I:
  • Paclitaxel, ifosfamide, and autologous peripheral blood stem cell (PBSC) collection: Patients receive paclitaxel IV over 3 hours on day 1 and ifosfamide IV over 2 hours on days 1-3. Patients undergo leukapheresis on days 11-13. Patients also receive filgrastim (G-CSF) subcutaneously (SC) twice daily beginning on day 3 and continuing until leukapheresis is completed. Beginning on day 14 or 21, patients may receive a second course of paclitaxel, ifosfamide, and G-CSF. Patients may also undergo additional leukapheresis.
  
  
  
  • Paclitaxel, carboplatin, ifosfamide, and autologous PBSC transplantation: Patients receive paclitaxel IV over 3 hours, high-dose carboplatin IV over 30 minutes, and ifosfamide IV over 4 hours on days 1-3. Patients also receive G-CSF SC beginning on day 3 and continuing until blood counts recover. Patients undergo reinfusion of autologous PBSCs on day 5. Treatment repeats every 21-28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

    Cohorts of 3-6 patients receive escalating doses of paclitaxel, carboplatin, and ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  
  
  



• Phase II: Patients receive treatment as in phase I with paclitaxel, carboplatin, and ifosfamide at the MTD determined in phase I.

After completion of study treatment, patients are followed periodically for 1 year and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Darren Feldman, MD, Principal investigator		Ph: 646-422-4491; 800-525-2225

U.S.A.
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Darren Feldman, MD	Ph:  646-422-4491 800-525-2225

Registry Information
Official Title		Phase I/II Trial of Sequential Paclitaxel/Ifosfamide Followed by Dose-Escalated, Dose-Intensive Carboplatin, Paclitaxel and Ifosfamide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients
Trial Start Date		2006-08-22
Trial Completion Date		2009-08-24 (estimated)
Registered in ClinicalTrials.gov		NCT00423852
Date Submitted to PDQ		2006-11-15
Information Last Verified		2009-07-06
NCI Grant/Contract Number		CA08748

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