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Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.

Sponsors and Collaborators: Fox Chase Cancer Center
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

MedlinePlus related topics:   Cancer    Kidney Cancer   

Drug Information available for:   Bryostatin 1   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

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
National Cancer Institute (NCI)

Investigators
Study Chair:     Naomi S. Balzer-Haas, MD     Fox Chase Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

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

Study placed in the following topic categories:
Urogenital Neoplasms
Bryostatin 1
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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