Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00002489|
Recruitment Status : Completed
First Posted : August 30, 2004
Last Update Posted : June 26, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have non-testicular malignant germ cell tumors.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Ovarian Cancer||Biological: dactinomycin Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate Procedure: conventional surgery||Phase 2|
OBJECTIVES: I. Determine the efficacy of cyclophosphamide, carboplatin, and etoposide in patients with non-testicular malignant germ cell tumors. II. Improve the quality of life of these patients by shortening the length of treatment and the extent of initial surgical resection. III. Determine whether histologic subtypes have prognostic significance. IV. Determine the efficacy of short term chemotherapy in this patient population. V. Determine the role of second look surgery in predicting curability of non testicular germ cell tumors. VI. Determine the role of dose intensification of cyclophosphamide and the introduction of doxorubicin, methotrexate, and dactinomycin for those patients with partial response, no response, or progressive disease at the time of second look surgery.
OUTLINE: Patients undergo treatment on Regimen A consisting of surgical resection of tumor as appropriate for disease followed by chemotherapy with cyclophosphamide IV over 20 minutes on day 1, carboplatin IV on day 2, and etoposide IV on days 2-4. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24-48 hours following the last dose of etoposide and continuing for 14 days or until blood counts recover (a total of 28 days). Chemotherapy repeats every 3 weeks for 4 courses in the absence of disease progression. At week 11, patients undergo second look surgery to evaluate response and resect any residual disease. Patients with no residual disease receive no further therapy. Patients with good partial response or no response receive salvage chemotherapy on Regimen B. Patients receive salvage chemotherapy on Regimen B consisting of dactinomycin IV on days 1-3, doxorubicin IV and vincristine IV continuously on days 1-3, and G-CSF SQ daily beginning 24-48 hours following last dose of vincristine and continuing for 14 days or until blood counts recover. At week 3, patients receive cyclophosphamide IV on days 1-2, vincristine IV and doxorubicin IV continuously on days 1-3 and G-CSF as previously given in Regimen B. At week 6, patients receive methotrexate IV on day 1 and leucovorin calcium orally or IV every 6 hours for 3 days, beginning 16 hours after the completion of methotrexate. At week 8, salvage chemotherapy repeats for an additional course. Patients achieving complete response following salvage chemotherapy receive no further therapy. Patients with no response are removed from study.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study over 6 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS|
|Study Start Date :||October 1991|
|Actual Primary Completion Date :||June 2002|
|Actual Study Completion Date :||June 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002489
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Norma Wollner, MD||Memorial Sloan Kettering Cancer Center|