|Estimated Enrollment Submitted:||February/4/2007|
|Last Update Submitted:||September/28/2020|
|Last Update Posted:||September/30/2020|
|Actual Study Start Date:||December/18/2006|
|Estimated Primary Completion Date:||September/30/2021|
|Estimated Study Completion Date:||September/30/2021|
|Masking:||None (Open Label)|
|Experimental: 2 Transplants|
Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.
|Drug: 2 Transplants|
Days -6, -5, -4: 500mg/m2^/day intravenously (IV) over 60 minutes
|Active Comparator: 1 Transplant|
Patients with Germ cell tumors who receive one transplant only.
|Drug: 1 Transplant|
2500 mg/m^2/day continuous infusion intravenously on Days -6, -5 and -4.
|Ages Eligible for Study:||10 Years to 10 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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:
- Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days or Aranesp for 21 days
- White blood cells (WBC) > 2.5 x 10^9/L with an absolute neutrophile count (ANC) > 1.5 x 10^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
- Platelets > 100 x 10^9/L without transfusion and/or a bone marrow cellularity of ≥ 20%
- 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.
- Patients with serious uncontrolled infections will not be eligible.
- Male and female patients of reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for the duration of study participation. The drugs used in this study are pregnancy category D - clear evidence of risk in pregnancy.
- Pregnant and breast feeding women will not be eligible.
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:
- WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
- Platelets > 50 x 10^9/L without transfusion in the prior 7 days
- 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
- 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.