Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
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|ClinicalTrials.gov Identifier: NCT00002508|
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : October 1, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor||Drug: carboplatin Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official 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|
|Study Start Date :||November 1990|
|Actual Primary Completion Date :||September 2001|
|Actual Study Completion Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002508
|United States, Pennsylvania|
|Temple University Cancer Center|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Chair:||Thomas R. Klumpp, MD||Fox Chase Cancer Center|