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Winston-Salem, North Carolina 27157


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.


Study summary:

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.


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


NCT ID:

NCT00002943


Primary Contact:

Study Chair
David D. Hurd, MD
Wake Forest University Health Sciences


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 18, 2017

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