- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005056
Bryostatin 1 In Treating Patients With Progressive Kidney Cancer
A Phase II Trial of Bryostatin-1 in Hypernephroma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have progressive kidney cancer
Study Overview
Detailed Description
OBJECTIVES: I. Determine the response rates in patients with progressive hypernephroma treated with bryostatin 1. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive bryostatin 1 IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. For patients with stable or responding disease after completion of course 2, treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 12-18 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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England
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Oxford, England, United Kingdom, 0X3 7LJ
- Oxford Radcliffe Hospital
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Oxford, England, United Kingdom, OX3 7LJ
- Imperial Cancer Research Fund Medical Oncology Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS: Histologically proven progressive hypernephroma Bidimensionally measurable disease with documented progression within 2 months prior to study entry Sites of measurable or evaluable disease must be outside prior radiation ports No active symptomatic CNS disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: Granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.17 mg/dL SGOT or SGPT less than 2.5 times normal Renal: Creatinine less than 1.70 mg/dL Other: No other prior or concurrent malignancy except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer No severe or uncontrolled nonmalignant systemic disease that would make the patient a poor medical risk No uncontrolled active infection Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: No prior chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy or steroids and recovered No concurrent systemic steroids Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Adrian L. Harris, MD, Oxford University Hospitals NHS Trust
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Bryostatin 1
Other Study ID Numbers
- CRC-PHASE-I/II-PH2/034
- CDR0000067651 (Registry Identifier: PDQ (Physician Data Query))
- EU-20001
- NCI-T95-0024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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