A Phase II Trial of Bryostatin 1 in Ovarian Cancer Administered by Weekly 24 Hour Intravenous Infusion
bryostatin 1
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: July 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: Evaluate the antitumor activity and toxicity of bryostatin 1 in patients with platinum resistant ovarian epithelial cancer. Determine the response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours. Treatment repeats weekly for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable or regressive disease may receive additional treatment. Patients are followed for at least 4 weeks after treatment, then every 3 months. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
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.Over 18 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 proven ovarian epithelial cancer Progressive disease during or after completion of at least one platinum based chemotherapy regimen Bidimensionally measurable disease At least 2 cm by x-ray, CT scan, or ultrasound No active, symptomatic brain metastases (e.g., cerebral edema and/or progressive tumor growth) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.7 mg/dL AST/ALT no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.4 mg/dL Other: No active, uncontrolled infection No nonmalignant systemic disease which would increase risk to patient No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No more than 2 prior multidrug chemotherapy regimens No more than 1 prior single agent chemotherapy regimen Endocrine therapy: At least 4 weeks since prior endocrine therapy and recovered No concurrent steroids Concurrent hormone replacement therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy (excluding palliative therapy) and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major thoracic or abdominal surgery Other: No other concurrent anticancer therapy or investigational drugs
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 4 locations
Christie Hospital N.H.S. Trust
Manchester, United KingdomOpen Christie Hospital N.H.S. Trust in Google MapsOxford Radcliffe Hospital
Oxford, United KingdomWeston Park Hospital
Sheffield, United KingdomRoyal Infirmary
Glasgow, United Kingdom