Status:
COMPLETED
Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
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:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
Detailed Description
OBJECTIVES: * Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-ris...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed germ cell tumor meeting 1 of the following criteria:
- Poor risk, defined by any of the following:
- Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
- Pretreatment serum lactate dehydrogenase (LDH) \> 10 times upper limit of normal (ULN)
- Pretreatment serum human chorionic gonadotropin (HCG) \> 50,000 IU/L
- Pretreatment serum alpha fetoprotein (AFP) \> 10,000 ng/mL
- Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
- Bone metastases
- Brain metastases
- Hepatic metastases
- Any nonpulmonary metastases (i.e., skin, spleen)
- Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
- Modified intermediate risk, defined by any of the following:
- Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
- Pretreatment serum LDH 3.0-10 times ULN
- Pretreatment serum HCG 5,000-50,000 IU/L
- Pretreatment serum AFP 1,000-10,000 ng/mL
- Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
- Bone metastases
- Brain metastases
- Hepatic metastases
- Any nonpulmonary visceral metastases (i.e., skin, spleen)
- Previously untreated disease
- Measurable or evaluable disease
- PATIENT CHARACTERISTICS:
- WBC ≥ 3,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Creatinine normal or creatinine clearance \> 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
- AST and ALT ≤ 3 times ULN
- Bilirubin ≤ 2.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent malignancy except for nonmelanoma skin cancer
- No known HIV positivity
- No active infections
- PRIOR CONCURRENT THERAPY:
- Recovered from prior surgery
- More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
- No prior chemotherapy
- No other concurrent cytotoxic therapy
- Concurrent radiotherapy and surgery allowed for treatment of brain metastases
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00470366
Start Date
March 1 2007
End Date
June 1 2016
Last Update
November 28 2017
Active Locations (2)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065