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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005604 |
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.
Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining the two drugs may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 plus interleukin-2 in treating patients who have advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: aldesleukin Biological: recombinant interleukin-12 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Twice Weekly IV IL-12 Plus Low-Dose Subcutaneous IL-2 in Patients With Advanced Malignancies |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive interleukin-12 (IL-12) IV on days 1 and 4 for 6 weeks. Beginning on day 4 of the third week, patients receive interleukin-2 (IL-2) subcutaneously 1 hour before and 20 hours after each dose of IL-12. On subsequent courses, IL-2 and IL-12 are administered on days 1 and 4 of each week.
Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease response may continue treatment until complete response or disease progression.
Cohorts of 3-6 patients receive escalating doses of IL-12 and IL-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.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Study Chair: | Michael B. Atkins, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | CDR0000067723, BIH-99-1332, NCI-65 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005604 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Anti-HIV Agents Interleukin-12 Aldesleukin Anti-Retroviral Agents Immunologic Factors |
Interleukin-2 Adjuvants, Immunologic Antiviral Agents Angiogenesis Inhibitors |
Anti-Infective Agents Interleukin-12 Anti-HIV Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Aldesleukin Anti-Retroviral Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |