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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Bryostatin 1; Interleukin-2

Criteria

Inclusion Criteria:

• 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

• No psychiatric illness or social situation that would preclude study entry

• No prior interleukin-2

• See Disease Characteristics

• See Disease Characteristics

• Prior radiotherapy to less than 50% of bone marrow allowed

• At least 4 weeks since prior radiotherapy

• See Disease Characteristics

• No other concurrent investigational agents

• No concurrent combination antiretroviral therapy for HIV-positive patients