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

National Cancer Institute (NCI)65 enrolled

Overview

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

PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced renal cell carcinoma treated with interleukin-2 (IL-2) and bryostatin 1. II. Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a fixed dose of IL-2 in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three dose levels of bryostatin 1. ARM I: Patients receive interleukin-2 (IL-2) subcutaneously on days 1-4, 8-11, and 15-18. For the second and subsequent courses of IL-2, patients also receive lowest dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive IL-2 as in arm I and middle dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. ARM III: Patients receive IL-2 as in arm I and highest dose bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive 3 additional courses of therapy. An additional cohort of patients receives treatment as above at a higher dose to evaluate toxicity. Patients are followed for 1 year. PROJECTED ACCRUAL: A total of 24-65 patients (8-16 per bryostatin 1 dose level) will be accrued for this study within 14-27 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Recurrent Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer

Interventions

aldesleukinBIOLOGICAL

Given subcutaneously

bryostatin 1DRUG

Given IV

laboratory biomarker analysisOTHER

Correlative studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Overall response (CR and PR)

Will be comparing using Fisher's exact test.

Time frame: Up to 1 year

Time to disease progression

Kaplan-Meier estimates will be generated.

Time frame: From the date of registration to the date of progressive disease or death

Overall survival

Kaplan-Meier estimates will be generated.

Time frame: Up to 1 year

Disease-free survival

Will be compared using the logrank test.

Time frame: Up to 1 year

Secondary Outcomes

All observed toxicities assessed using CTC version 2.0

A chi-square test and one-way ANOVA will be used for categorical and continuous toxicity endpoints, respectively.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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