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INTENSIVE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY GERM CELL TUMORS EMPLOYING HIGH-DOSE CARBOPLATIN, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS BONE MARROW RESCUE FOR PATIENTS 15 TO 60 YEARS OF AGE


Phase 1/Phase 2
15 Years
60 Years
Not Enrolling
Both
Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Thank you

Trial Information

INTENSIVE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY GERM CELL TUMORS EMPLOYING HIGH-DOSE CARBOPLATIN, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS BONE MARROW RESCUE FOR PATIENTS 15 TO 60 YEARS OF AGE


OBJECTIVES: I. Determine the response rate, overall survival, and disease-free survival of
patients with refractory or relapsed germ cell carcinoma treated with high-dose induction
chemotherapy comprising carboplatin and etoposide followed by autologous bone marrow or
peripheral blood stem cell rescue.

OUTLINE: Autologous peripheral blood stem cells (PBSC) or bone marrow is harvested. Patients
receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3.
Autologous PBSC or bone marrow is reinfused on day 0.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Documented relapsed or refractory germ cell cancer of the
following sites of origin: Testes Ovary Retroperitoneum Mediastinum Other sites Any stage
of disease allowed Any histologic subtype allowed Seminoma only allowed if ineligible for
radiotherapy Failed to achieve complete remission (CR) following at least 3 courses of a
standard platinum-containing regimen or experienced clear relapse following CR obtained
with such a regimen Absence of tumor markers in the presence of stable residual masses
after initial treatment may be allowed (surgical biopsy should be performed; if medically
safe, to confirm persistence of disease and rule out mature teratoma or fibrosis) Prior
CNS involvement allowed in the absence of gross residual CNS tumor following definitive
local therapy (surgery plus radiotherapy) No gross tumor involvement on bone marrow biopsy

PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: Karnofsky 80-100%
Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal Albumin greater
than 3.0 mg/dL Renal: Creatinine less than 1.8 mg/dL Cardiovascular: LVEF at least 50% No
other serious cardiac disease that would preclude transplantation Pulmonary: DLCO, FEV1,
and FVC at least 50% predicted pO2 at least 70 mm Hg on room air Other: HIV negative No
other concurrent serious psychiatric, neurologic, neoplastic, immunologic, or other
medical problem that would preclude transplantation Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
No prior chest irradiation Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas R. Klumpp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000078063

NCT ID:

NCT00002508

Start Date:

November 1990

Completion Date:

September 2001

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • recurrent ovarian germ cell tumor
  • extragonadal germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Temple University Cancer CenterPhiladelphia, Pennsylvania  19140