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Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: October 12, 2008   History of Changes
Sponsor: Fox Chase Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003968
  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 metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: bryostatin 1
Phase II

Study Type: Interventional
Study Design: 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):

Study Start Date: June 1999
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.

PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.

  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 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,00/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Other: 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: Biologic therapy: No more than 1 prior therapy with biologic response modifiers Chemotherapy: No prior chemotherapy for advanced disease No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent steriods (except topical use) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since major surgery (including nephrectomy) Other: No other concurrent experimental agents

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003968

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000067169, FCCC-99012, NCI-T99-0002
Study First Received: November 1, 1999
Last Updated: October 12, 2008
ClinicalTrials.gov Identifier: NCT00003968     History of Changes
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 09, 2009