Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

February 7, 2013 updated by: National Cancer Institute (NCI)

Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.

II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.

IV. Determine the overall survival of this patient population treated with this regimen.

OUTLINE:

Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Regional Cancer Center
      • Lakewood, New Jersey, United States, 08701
        • Kimball Medical Center
      • Millville, New Jersey, United States, 08332
        • South Jersey Hospital - Millville
      • Mount Holly, New Jersey, United States, 08060
        • Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
      • Red Bank, New Jersey, United States, 07701
        • Riverview Medical Center
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
      • Trenton, New Jersey, United States, 08629
        • St. Francis Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Bon Secours-Holy Family Health System
      • Drexel Hill, Pennsylvania, United States, 19026
        • Delaware County Memorial Hospital
      • Harrisburg, Pennsylvania, United States, 17105-8700
        • Pinnacle Health Hospitals
      • Johnstown, Pennsylvania, United States, 15905
        • Conemaugh Memorial Hospital
      • Langhorne, Pennsylvania, United States, 19047
        • Saint Mary Medical Center
      • Lansdale, Pennsylvania, United States, 19446
        • North Penn Hospital
      • Paoli, Pennsylvania, United States, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Memorial Regional Cancer Center
      • Reading, Pennsylvania, United States, 19612-6052
        • Reading Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma
  • Bidimensionally measurable disease
  • Clear evidence of progression if only site of measurable disease is within previous radiation port
  • Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0-1
  • Life expectancy: Greater than 3 months
  • WBC at least 3,000/mm3
  • Platelet count at least 100,00/mm3
  • Bilirubin no greater than 1.5 mg/dL
  • Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study
  • No active bacterial or viral infection
  • No serious underlying medical condition that would interfere with compliance
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin
  • No dementia or altered mental status that would prevent informed consent

PRIOR CONCURRENT THERAPY:

  • No more than 1 prior therapy with biologic response modifiers
  • No prior chemotherapy for advanced disease
  • No other concurrent chemotherapy
  • No concurrent steriods (except topical use)
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • At least 4 weeks since major surgery (including nephrectomy)
  • No other concurrent experimental agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Drug: bryostatin 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Naomi S. Balzer-Haas, MD, Fox Chase Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 30, 2004

First Posted (Estimate)

May 3, 2004

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02303
  • FCCC-99012
  • NCI-T99-0002
  • CDR0000067169 (Registry Identifier: PDQ (Physician Data Query))

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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