Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor risk category or others who relapse can be successfully salvaged with high dose chemotherapy and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential high dose chemotherapy and AuSCT may improve overall and disease free survival.
PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose investigating how well non-cross resistant conditioning regimens work in treating patients with relapsed or high risk GCT.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed at 6, 9, and 12 months and then every 6 months for up to 2 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Inclusion Criteria:
Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2 as defined by the International Germ Cell Cancer Consensus Classification. Patients with increasing tumor markers only (i.e. no imaging evidence of progressive disease) are eligible for transplant.
Age: ≥ 10 years and < 70 years of age.
Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for subject 10 - 15 years of age
Life expectancy: Greater than 8 weeks.
Patients must have normal organ function as defined below:
Hematologic:
Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min.
Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper limit of normal. No history of severe prior or ongoing chronic liver disease.
Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. LVEF ≥45% by MUGA/ECHO.
Pulmonary: Patients must have no significant obstructive airways disease (FEV1 must be ≥ 50% of predicted) and must have acceptable diffusion capacity (corrected DLCO > 50% of predicted).
Patients with a history of CNS tumor involvement are eligible if they have completed treatment for CNS disease (radiotherapy or surgery or chemotherapy), have recovered from or stabilization of the side effects associated with the therapy and have no evidence of progressive CNS disease at the time of enrollment.
Exclusion Criteria:
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Additional Eligibility prior to Transplant Two:
Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one
Transplant able to occur between day +30 and day +90 from transplant one
Recovery of blood counts as demonstrated by:
Infection: Patients with serious uncontrolled infections at the time of planned transplant will be excluded
Patients with progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria by imaging techniques are not eligible to proceed to the second transplant. Tumor marker increase alone is not sufficient to diagnose disease progression.