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Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Interventions
Registration Number
NCT00003968
Lead Sponsor
National Cancer Institute (NCI)
Brief Summary

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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Arm Ibryostatin 1Patients 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.
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (17)

Kimball Medical Center

🇺🇸

Lakewood, New Jersey, United States

South Jersey Hospital - Millville

🇺🇸

Millville, New Jersey, United States

Riverview Medical Center

🇺🇸

Red Bank, New Jersey, United States

Community Medical Center

🇺🇸

Toms River, New Jersey, United States

Delaware County Memorial Hospital

🇺🇸

Drexel Hill, Pennsylvania, United States

Bon Secours-Holy Family Health System

🇺🇸

Altoona, Pennsylvania, United States

Pottstown Memorial Regional Cancer Center

🇺🇸

Pottstown, Pennsylvania, United States

Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County

🇺🇸

Mount Holly, New Jersey, United States

Pinnacle Health Hospitals

🇺🇸

Harrisburg, Pennsylvania, United States

North Penn Hospital

🇺🇸

Lansdale, Pennsylvania, United States

Hunterdon Regional Cancer Center

🇺🇸

Flemington, New Jersey, United States

Fox Chase Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Saint Mary Medical Center

🇺🇸

Langhorne, Pennsylvania, United States

Conemaugh Memorial Hospital

🇺🇸

Johnstown, Pennsylvania, United States

Paoli Memorial Hospital

🇺🇸

Paoli, Pennsylvania, United States

St. Francis Medical Center

🇺🇸

Trenton, New Jersey, United States

Reading Hospital and Medical Center

🇺🇸

Reading, Pennsylvania, United States

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