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Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Massey Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006022
  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 I

MedlinePlus related topics: Cancer Kidney Cancer Melanoma
Drug Information available for: Bryostatin 1 Interleukin-2 Aldesleukin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control
Official Title: Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)

Further study details as provided by National Cancer Institute (NCI):

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
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
Massey Cancer Center
Investigators
Study Chair: John D. Roberts, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068034, MCV-MCC/CCHR-9910-2A, NCI-T99-0049
Study First Received: July 5, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00006022     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Urinary Tract Neoplasm
Immunologic Factors
Urogenital Neoplasms
Urologic Neoplasms
Melanoma
Renal Cancer
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Kidney Diseases
Analgesics
Kidney Cancer
Anti-HIV Agents
Adjuvants, Immunologic
Bryostatin 1
Antiviral Agents
Recurrence
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Carcinoma, Renal Cell
Peripheral Nervous System Agents
Nevus
Adenocarcinoma

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Urologic Neoplasms
Melanoma
Neoplasms by Site
Anti-Retroviral Agents
Urologic Diseases
Sensory System Agents
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Analgesics
Kidney Diseases
Anti-HIV Agents
Neoplasms by Histologic Type
Adjuvants, Immunologic
Bryostatin 1
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Interleukin-2

ClinicalTrials.gov processed this record on May 06, 2009