Phase II Study of High Dose Cyclophosphamide, Mitoxantrone, and Carboplatin With Autologous Bone Marrow Transplantation in Refractory or Relapsed Ovarian Carcinoma
carboplatin
+ cyclophosphamide
+ mitoxantrone hydrochloride
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: February 1, 1991
Actual date on which the first participant was enrolled.OBJECTIVES: Determine the response rate, duration of response, and overall survival of patients with refractory or relapsed ovarian epithelial cancer treated with high-dose cyclophosphamide, carboplatin, and mitoxantrone followed by autologous bone marrow transplantation. Determine the nonhematopoietic toxicity of this regimen in these patients. OUTLINE: Autologous bone marrow is harvested before study entry. Patients receive high-dose cyclophosphamide IV over 1 hour and mitoxantrone IV over 15 minutes on days -8, -6, and -4 and carboplatin IV continuously on days -8 to -3 in the absence of unacceptable toxicity. Bone marrow is reinfused on day 0 beginning at least 60 hours after completion of carboplatin infusion. Patients are followed for survival. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 1.5-3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Until 64 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: Diagnosis of refractory or relapsed ovarian epithelial cancer Must have failed prior regimen containing cisplatin or carboplatin Bidimensionally measurable or evaluable disease Serial CA-125 antigen titers or cytologically positive pleural effusion and/or ascites acceptable as evaluable disease Autologous bone marrow harvest of greater than 1.2 x 10 to the eighth nucleated cells/kg required before study entry No evidence of tumor at marrow harvest sites by bilateral bone marrow aspirates and biopsies, pelvic x-ray, and bone scan CNS involvement allowed PATIENT CHARACTERISTICS: Age: Under 65 Performance status: SWOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC greater than 3,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 10.0 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times upper limit of normal Renal: Creatinine clearance greater than 60 mL/min No prior hemorrhagic cystitis Cardiovascular: LVEF greater than 45% by MUGA scan Other: No hearing loss in voice tones No active infection No psychological contraindication to study treatment Not pregnant Negative pregnancy test HIV negative General medical condition must allow general anesthesia PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow transplantation More than 4 weeks since other prior biologic therapy and recovered Chemotherapy: See Disease Characteristics More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: More than 4 weeks since prior radiotherapy and recovered 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
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
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, United StatesOpen Cardinal Bernardin Cancer Center at Loyola University Medical Center in Google Maps