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


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response (CR and PR)

Outcome Description:

Will be comparing using Fisher's exact test.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Walter Stadler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02460

NCT ID:

NCT00032188

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell

Name

Location
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470