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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002508
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : October 1, 2010
Fox Chase Cancer Center
Information provided by:
Temple University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : November 1990
Actual Primary Completion Date : September 2001
Actual Study Completion Date : September 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002508

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United States, Pennsylvania
Temple University Cancer Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Fox Chase Cancer Center
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Study Chair: Thomas R. Klumpp, MD Fox Chase Cancer Center

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Responsible Party: Temple University Bone Marrow Transplant Program, Temple University health Systems Identifier: NCT00002508     History of Changes
Other Study ID Numbers: CDR0000078063
First Posted: March 11, 2004    Key Record Dates
Last Update Posted: October 1, 2010
Last Verified: September 2010
Keywords provided by Temple University:
recurrent malignant testicular germ cell tumor
recurrent ovarian germ cell tumor
extragonadal germ cell tumor
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action