Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer

Completed · Phase 2

Conditions studied: Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bryostatin 1 with interleukin-2 may cause a stronger immune response and kill more tumor cells. Randomized phase II trial to study the effectiveness of combining interleukin-2 and bryostatin 1 in treating patients who have advanced kidney cancer

Key facts

Study ID

NCT00032188

Run by

National Cancer Institute (NCI)

People needed

65

Starts

2002-01-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed renal cell carcinoma
• Recurrent or refractory advanced disease
• Newly diagnosed disease with no appropriate standard therapy available
• Measurable disease
• No active CNS metastases
• Single prior CNS metastasis allowed if all of the following are true:
• Previously resected and irradiated
• No evidence of progressive CNS disease for at least 8 weeks after completion of therapy
• No requirement for steroids or anti-seizure medications
• Performance status - ECOG 0-2
• More than 3 months
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST/ALT no greater than 2.5 times ULN
• Creatinine no greater than 2.0 mg/dL
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and for 3 months after study for male patients
• No concurrent uncontrolled illness
• No ongoing or active infection

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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