Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637-1470
- University of Chicago Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Arm I (aldesleukin and lowest dose bryostatin 1)
Patients receive 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.
|
Correlative studies
Given subcutaneously
Other Names:
Given IV
Other Names:
|
|
EXPERIMENTAL: Arm II (aldesleukin and middle dose bryostatin 1)
Patients receive IL-2 subcutaneously on days 1-4, 8-11, and 15-18.
For the second and subsequent courses of IL-2, patients also receive 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.
|
Correlative studies
Given subcutaneously
Other Names:
Given IV
Other Names:
|
|
EXPERIMENTAL: Arm III (aldesleukin and highest dose bryostatin 1)
Patients receive IL-2 subcutaneously on days 1-4, 8-11, and 15-18.
For the second and subsequent courses of IL-2, patients also receive 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.
|
Correlative studies
Given subcutaneously
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall response (CR and PR)
Time Frame: Up to 1 year
|
Will be comparing using Fisher's exact test.
|
Up to 1 year
|
|
Time to disease progression
Time Frame: From the date of registration to the date of progressive disease or death
|
Kaplan-Meier estimates will be generated.
|
From the date of registration to the date of progressive disease or death
|
|
Overall survival
Time Frame: Up to 1 year
|
Kaplan-Meier estimates will be generated.
|
Up to 1 year
|
|
Disease-free survival
Time Frame: Up to 1 year
|
Will be compared using the logrank test.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All observed toxicities assessed using CTC version 2.0
Time Frame: Up to 1 year
|
A chi-square test and one-way ANOVA will be used for categorical and continuous toxicity endpoints, respectively.
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Aldesleukin
- Bryostatin 1
- Interleukin-2
Other Study ID Numbers
- NCI-2012-02460
- 11367
- N01CM17102 (U.S. NIH Grant/Contract)
- CDR0000069267 (REGISTRY: PDQ (Physician Data Query))
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