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

Primary Purpose

Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
etoposide
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Temple University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor, extragonadal germ cell tumor

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
September 30, 2010
Sponsor
Temple University
Collaborators
Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002508
Brief Title
Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 1990 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
September 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Temple University
Collaborators
Fox Chase Cancer Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
Keywords
recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor, extragonadal germ cell tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R. Klumpp, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Temple University Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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