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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Melanoma (Skin)
• Intervention / Treatment: Biological: aldesleukin; Drug: bryostatin 1

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-0002
      • Norris Cotton Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: John D. Roberts, MD, Massey Cancer Center

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 14, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: stage IV renal cell cancer; recurrent renal cell cancer; recurrent melanoma; stage IV melanoma; stage III renal cell cancer; stage III melanoma
• 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; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Kidney Neoplasms; Carcinoma, Renal Cell; Melanoma; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Aldesleukin; Bryostatin 1
• Other Study ID Numbers: CDR0000068034; P30CA016059 (U.S. NIH Grant/Contract); MCV-MCC/CCHR-9910-2A; NCI-T99-0049