High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study
carboplatin
+ cyclophosphamide
+ etoposide
Urogenital Diseases+17
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: February 1, 1993
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, United StatesOpen Comprehensive Cancer Center at Wake Forest University in Google Maps