Bryostatin 1 In Treating Patients With Progressive Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

A Phase II Trial of Bryostatin-1 in Hypernephroma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005056
• Other study ID #: CRC-PHASE-I/II-PH2/034
• Secondary ID: CDR0000067651EU-
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: June 25, 2013
• Start date: March 1999
• Est. completion date: July 2006

Study information

• Verified date: June 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• bryostatin 1

Locations

Country	Name	City	State
United Kingdom	Imperial Cancer Research Fund Medical Oncology Unit	Oxford	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom,