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PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS


Phase 2
N/A
20 Years
Not Enrolling
Both
Extragonadal Germ Cell Tumor, Ovarian Cancer

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Trial Information

PROTOCOL FOR THE TREATMENT OF MALIGNANT NON-TESTICULAR GERM CELL TUMORS


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Norma Wollner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

91-119

NCT ID:

NCT00002489

Start Date:

October 1991

Completion Date:

June 2002

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • stage II ovarian germ cell tumor
  • stage III ovarian germ cell tumor
  • stage IV ovarian germ cell tumor
  • ovarian teratoma
  • extragonadal germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021