Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002508
• Date of registration: 01/11/1999
• Primary sponsor: Temple University
• Public title: Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
• Scientific title: 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
• Date of first enrolment: November 1990
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002508
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Thomas R. Klumpp, MD
• Affiliation: Fox Chase Cancer Center

Key inclusion & exclusion 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



Age minimum: 15 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Extragonadal Germ Cell Tumor

Ovarian Cancer

Testicular Germ Cell Tumor

Intervention(s)

Drug: carboplatin

Drug: etoposide

Procedure: autologous bone marrow transplantation

Procedure: peripheral blood stem cell transplantation

Secondary ID(s)

CDR0000078063

NCI-V92-0204

TUHSC-1839

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fox Chase Cancer Center