Germ Cell Tumor, Extragonadal |
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Clinical Trial: Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
This study has been suspended.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may help the body kill more tumor cells.
PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult solid tumor extragonadal germ cell tumor ovarian germ cell tumor Testicular Cancer | Drug: carboplatin Drug: cyclophosphamide Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Ovarian Cancer; Testicular Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation (ABMT) for Relapsed or Refractory Germ Cell Cancer and Other Chemotherapy-Sensitive Solid Tumors
OBJECTIVES:
- Investigate the response rate, duration of response, survival, time to marrow reconstitution, and toxicity of two successive cycles of high dose carboplatin, etoposide, and cyclophosphamide chemotherapy and ABMT in patients with relapsed and refractory germ cell cancer or other chemotherapy-sensitive solid tumors.
- Further define the pretransplant characteristics of patients and their disease that might influence the outcome of this therapy.
OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT.
At day 60 following ABMT, if the patient has a complete response (CR) or partial response (PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given when hematologic parameters and other criteria are acceptable. If there is no CR or PR and/or nonhematologic toxicity exceeds grade 2, a second ABMT is not given.
After ABMT patients are followed until disease progression or death.
PROJECTED ACCRUAL: Ten patients will be accrued for this pilot study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed, measurable germ cell cancer relapsed or refractory after frontline therapy with cisplatin and etoposide-containing chemotherapy
- Other chemotherapy-sensitive solid tumors eligible (as of 06/11/97)
- Possibility of residual mass representing benign teratoma must be excluded
- Elevated serum tumor markers only are acceptable if possibilities of false-positive serum tumor markers or sanctuary disease have been excluded
- Also eligible after two to four cycles of conventional dose salvage chemotherapy, regardless of response
- No CNS or bone marrow involvement
PATIENT CHARACTERISTICS: Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 2 months
Hematopoietic:
- Platelet count at least 100,000/mm3
- Neutrophil count at least 1,500/mm3
Hepatic:
- Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of normal, unless due to disease
Renal:
- Creatinine less than 1.5 times upper limit of normal
- Creatinine clearance at least 60 ml/min
Cardiovascular:
- Ventricular ejection fraction at least 45%
- No uncontrolled or severe cardiovascular disease including recent myocardial infarction, congestive heart failure, angina, life-threatening arrhythmia, or hypertension
Pulmonary:
- DLCO and spirometry greater than 50% of predicted
Other:
- Not HIV positive
- No active peptic ulcer
- No uncontrolled diabetes mellitus
- No active infection
- No previous or concomitant malignancy other than curatively treated basal or squamous cell carcinoma of the skin
- Not HBsAG positive
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- No prior high-dose carboplatin, etoposide, or cyclophosphamide
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Location Information
North Carolina
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States
David Duane Hurd, MD, Study Chair, Comprehensive Cancer Center of Wake Forest University
More Information
Record last reviewed: January 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002943
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Extragonadal Germ Cell Tumor (National Cancer Institute)

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