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Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors

Primary Purpose

Extragonadal Germ Cell Tumor, Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dactinomycin
filgrastim
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
leucovorin calcium
methotrexate
vincristine sulfate
conventional surgery
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian teratoma, extragonadal germ cell tumor

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 24, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002489
Brief Title
Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors
Official Title
PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 1991 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extragonadal Germ Cell Tumor, Ovarian Cancer
Keywords
stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian teratoma, extragonadal germ cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
dactinomycin
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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 PATIENT CHARACTERISTICS: Age: Child Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Wollner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Children With Non-testicular Malignant Germ Cell Tumors

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