Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003968
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: January 2004
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: bryostatin 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Resource links provided by NLM:


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

Enrollment: 35
Study Start Date: June 1999
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  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: NCT00003968

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

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003968     History of Changes
Other Study ID Numbers: NCI-2012-02303, FCCC-99012, NCI-T99-0002, CDR0000067169
Study First Received: November 1, 1999
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014