Bryostatin 1 In Treating Patients With Progressive Kidney Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005056
First received: April 6, 2000
Last updated: June 25, 2013
Last verified: June 2006
  Purpose

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


Condition Intervention Phase
Kidney Cancer
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Bryostatin-1 in Hypernephroma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1999
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005056

Locations
United Kingdom
Imperial Cancer Research Fund Medical Oncology Unit
Oxford, England, United Kingdom, OX3 7LJ
Oxford Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 7LJ
Sponsors and Collaborators
Cancer Research UK
Investigators
Study Chair: Adrian L. Harris, MD Oxford University Hospitals NHS Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005056     History of Changes
Other Study ID Numbers: CRC-PHASE-I/II-PH2/034, CDR0000067651, EU-20001, NCI-T95-0024
Study First Received: April 6, 2000
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bryostatin 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014