Germ Cell Tumor, Extracranial, Childhood |
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Clinical Trial: Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| recurrent testicular cancer recurrent ovarian germ cell tumor extragonadal germ cell tumor | Drug: carboplatin Drug: etoposide | Phase I Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Ovarian Cancer; Testicular Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I/II Pilot Study of High-Dose Carboplatin and Etoposide Followed By Stem Cell Rescue in Adults With Relapsed or Refractory Germ Cell Tumors
Study start: November 1990
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.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 15 Years - 60 Years
Criteria
PROTOCOL ENTRY 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
--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
--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
Location Information
Thomas R. Klumpp, Study Chair, Temple University Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002508
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Extracranial Germ Cell Tumor, Childhood (National Cancer Institute)

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