Germ Cell Tumor, Extracranial, Childhood |
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Clinical Trial: Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors
This study has been completed.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| stage IV ovarian germ cell tumor extragonadal germ cell tumor stage II ovarian germ cell tumor stage III ovarian germ cell tumor ovarian germ cell teratoma | Drug: carboplatin Drug: cyclophosphamide Drug: dactinomycin Drug: doxorubicin Drug: etoposide Drug: filgrastim Drug: leucovorin calcium Drug: methotrexate Drug: vincristine | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Ovarian Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Surgery Followed by Cyclophosphamide, Carboplatin, and Etoposide in Children With Non Testicular Malignant Germ Cell Tumors and Salvage Chemotherapy With Dactinomycin, Doxorubicin, Vincristine, and Cyclophosphamide, Vincristine, Doxorubicin, and High Dose Methotrexate for Those With Less Than Complete Response At Second Look Surgery
Study start: 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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: up to 20 Years
Criteria
PROTOCOL ENTRY CRITERIA:
--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
--Prior/Concurrent Therapy--
- Not specified
--Patient Characteristics--
- Age: Child
- Performance status: Not specified
- Hematopoietic: Not specified
- Hepatic: Not specified
- Renal: Not specified
Location Information
Norma Wollner, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002489
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Extracranial Germ Cell Tumor, Childhood (National Cancer Institute)

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