Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

Virginia Commonwealth University (VCU)

Status and phase

Completed

Phase 1

Conditions

Melanoma (Skin)

Kidney Cancer

Treatments

Drug: bryostatin 1

Biological: aldesleukin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00006022

CDR0000068034

P30CA016059 (U.S. NIH Grant/Contract)

MCV-MCC/CCHR-9910-2A

NCI-T99-0049

Details and patient eligibility

About

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.

Full description

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.

Enrollment

17 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: