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


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Benign Tumor

Benign Tumors; Cancer, Benign; Tumors, Benign


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.

Sponsored by: Temple University Cancer Center
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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


Pennsylvania
      Temple University Cancer Center, Philadelphia,  Pennsylvania,  19140,  United States

Study chairs or principal investigators

Thomas R. Klumpp,  Study Chair,  Temple University Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000078063; TUHSC-1839; NCI-V92-0204
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


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October 12, 2008



Page Updated: December 17, 2004
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