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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006022
• Other study ID #: CDR0000068034
• Secondary ID: P30CA016059MCV-M
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2000
• Last updated: December 10, 2015
• Start date: September 2000
• Est. completion date: January 2004

Study information

• Verified date: December 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2004
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

Drug:
• bryostatin 1

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,