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

Original Study ID : CDR0000068034

Secondary ID : Array

NCT ID : NCT00006022

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

Official Title : Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)

Brief Summary :

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.

Source : National Cancer Institute (NCI)

Detailed 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.

Overall Status : Completed

Start Date : September 2000

Official Title : Phase 1

Phase : Interventional

Study Design : Treatment, Randomized, Double-Blind, Active Control

Verification Date : August 2003

First Received Date : July 5, 2000

Trial Eligibility

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:

- 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Norris Cotton Cancer Center

City : Lebanon

State : New Hampshire

Zip Code : 03756-0002

Country : United States

Facility Name : Massey Cancer Center

City : Richmond

State : Virginia

Zip Code : 23219

Country : United States

Interventions

Type : Biological

Name : aldesleukin

Type : Drug

Name : bryostatin 1

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