Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
| Status: | Completed |
|---|---|
| Conditions: | Skin Cancer, Cancer, Cancer, Kidney Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 4/21/2016 |
| Start Date: | September 2000 |
| End Date: | January 2004 |
Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to
kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus
bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed
during surgery.
so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to
kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus
bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed
during surgery.
OBJECTIVES:
- Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose
interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell
proliferation in patients with melanoma or renal cell carcinoma.
- Assess other intermediate markers of immune response in patients treated with this
regimen.
- Determine tumor responses, response durations, progression-free intervals, and survival
of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three
bryostatin 1 dose levels.
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1
hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
- Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose
interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell
proliferation in patients with melanoma or renal cell carcinoma.
- Assess other intermediate markers of immune response in patients treated with this
regimen.
- Determine tumor responses, response durations, progression-free intervals, and survival
of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three
bryostatin 1 dose levels.
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1
hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell
carcinoma
- Unresectable disease
- No known uncontrolled CNS metastases
- CNS metastases allowed only if recently irradiated or known to be controlled
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 8 g/dL
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Absolute lymphocyte count at least 1,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 mg/dL OR
- Conjugated bilirubin no greater than 0.3 mg/dL
- AST no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 2 mg/dL
Cardiovascular:
- No myocardial infarction within the past 6 months
- No uncontrolled hypertension, angina, or congestive heart failure
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 3 months after study
- No known intolerance to acetaminophen
- No primary or secondary immunodeficiency
- No other condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- At least 1 month since prior topical, systemic, or inhaled corticosteroids
- No concurrent topical, systemic, or inhaled corticosteroids
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
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