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A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells (NCT00003993)

National Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.
  • Biological: aldesleukin
    • Drug: bryostatin 1
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.

      - Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.

      - Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.

      - Assess any anti-tumor response in these patients treated with this regimen.

      OUTLINE: This is a dose escalation study of interleukin-2.

      Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

      PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.

      1 locations

      United States (1)
      • National Institute on Aging - Baltimore
        Baltimore, Maryland, United States, 21224-6825
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 August, 1999
      Updated:
      27 April, 2015
      Participants:
      24
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