Bryostatin 1 In Treating Patients With Progressive Kidney Cancer

NCT ID: NCT00005056

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2006-07-31

Brief Summary

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

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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bryostatin 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Research UK

OTHER

Sponsor Role: lead

Principal Investigators

Adrian L. Harris, MD

Role: STUDY_CHAIR

Oxford University Hospitals NHS Trust

Locations

Oxford Radcliffe Hospital

Oxford, England, United Kingdom

Imperial Cancer Research Fund Medical Oncology Unit

Oxford, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000067651

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20001

Identifier Type: -

Identifier Source: secondary_id

NCI-T95-0024

Identifier Type: -

Identifier Source: secondary_id

CRC-PHASE-I/II-PH2/034

Identifier Type: -

Identifier Source: org_study_id