Status:
COMPLETED
Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from d...
Detailed Description
OBJECTIVES: * Determine the safety of paclitaxel and ifosfamide followed by dose-escalated, dose-intensive paclitaxel, carboplatin, and ifosfamide with autologous peripheral blood stem cell support i...
Eligibility Criteria
Inclusion
- 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
- PATIENT CHARACTERISTICS:
- Platelet count ≥ 100,000/mm\^3
- WBC ≥ 3,000/mm\^3
- 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
- Hepatitis C negative serology by RIBA or PCR
- Adequate medical condition for general anesthesia
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00423852
Start Date
August 1 2006
End Date
February 1 2013
Last Update
May 18 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065