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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Intervention: aldesleukin (Biological); bryostatin 1 (Drug); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Walter Stadler, Principal Investigator, Affiliation: University of Chicago Comprehensive Cancer Center

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

Clinical Details

Official title: A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Overall response (CR and PR)

Time to disease progression

Overall survival

Disease-free survival

Secondary outcome: All observed toxicities assessed using CTC version 2.0

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637-1470, United States
Additional Information

Starting date: January 2002
Last updated: January 23, 2013

Page last updated: August 23, 2015

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