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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00006022
First received: July 5, 2000
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Biological: aldesleukin
Drug: bryostatin 1
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Enrollment: 17
Study Start Date: September 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006022

Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Study Chair: John D. Roberts, MD Massey Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute
ClinicalTrials.gov Identifier: NCT00006022     History of Changes
Other Study ID Numbers: CDR0000068034, P30CA016059, MCV-MCC/CCHR-9910-2A, NCI-T99-0049
Study First Received: July 5, 2000
Last Updated: February 23, 2010
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Bryostatin 1
Interleukin-2
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014