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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002489 |
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 | Intervention | Phase |
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Extragonadal Germ Cell Tumor Ovarian Cancer |
Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS |
Study Start Date: | October 1991 |
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.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Malignant germ cell tumors of the following stages and primary sites: Stage II/III/IV ovarian tumors Grade II/III immature glial teratomas Stage II/III/IV mediastinal tumors Stage II/III/IV presacral tumors and tumors of other primary sites No intracranial or testicular primary sites
PATIENT CHARACTERISTICS: Age: Child Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
PRIOR CONCURRENT THERAPY: Not specified
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 |
Study ID Numbers: | CDR0000077384, MSKCC-91119, NCI-V92-0021 |
Study First Received: | November 1, 1999 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002489 |
Health Authority: | United States: Federal Government |
stage II ovarian germ cell tumor stage III ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian teratoma extragonadal germ cell tumor |
Gonadal Disorders Leucovorin Urogenital Neoplasms Ovarian Diseases Cyclophosphamide Etoposide phosphate Genital Diseases, Female Dactinomycin Neoplasms, Germ Cell and Embryonal Methotrexate Etoposide Extragonadal Germ Cell Tumor Endocrine Gland Neoplasms |
Ovarian cancer Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Vincristine Carboplatin Malignant germ cell tumor Doxorubicin Folic Acid Calcium, Dietary Endocrinopathy Teratoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Antibiotics, Antineoplastic Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses Vitamins Abortifacient Agents Micronutrients |
Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Vitamin B Complex Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Protein Synthesis Inhibitors |