Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.

PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMedicines
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Interleukin-2

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed renal cell cancer No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: No hepatic failure No encephalopathy Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: No renal dysfunction requiring dialysis for greater than 72 hours Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of sustained ventricular tachycardia (greater than 5 beats) No uncontrolled cardiac rhythm disturbances No recurrent chest pain with echocardiogram changes No angina No myocardial infarction No pericardial tamponade No moderate or severe coronary artery disease (New York Heart Association class 3 or 4) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant neurological dysfunction including seizure or clinical signs of other significant neurological disease No gastrointestinal bleeding requiring surgery No concurrent infection requiring antimicrobial therapy No bowel ischemia or perforation

PRIOR CONCURRENT THERAPY: At least 30 days since prior investigational drugs No other concurrent investigational drugs No intubation required for greater than 72 hours No prior enrollment in this study