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

This study has been completed.

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)
Drug: aldesleukin
Drug: bryostatin 1
Phase I

MedlinePlus related topics:   Cancer    Kidney Cancer    Melanoma   

ChemIDplus related topics:   Aldesleukin    Interleukin-2    Bryostatin 1   

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
National Cancer Institute (NCI)

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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068034, MCV-MCC/CCHR-9910-2A, NCI-T99-0049
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006022
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:
Urogenital Neoplasms
Bryostatin 1
Renal cancer
Kidney cancer
Urologic Neoplasms
Recurrence
Melanoma
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Urologic Diseases
Interleukin-2
Kidney Neoplasms
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Carcinoma, Renal Cell
Neuroepithelioma
Nevus
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nevi and Melanomas
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008




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