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Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. PURPOSE: This phase I trial is studying the side effects and best dose of interferon alfa in treating patients with stage IV solid tumors, lymphoma, or myeloma.
OBJECTIVES: * Confirm tolerance and safety of interferon alfa-1b (IFN-α1b) in patients with stage IV solid tumors, lymphoma, or myeloma. * Determine the maximum tolerated dose (MTD) of IFN-α1b given daily by subcutaneous injection in these patients. OUTLINE: This is a dose-escalation study. Patients receive interferon alfa-1b subcutaneously once daily for at least 1 month. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of interferon alfa-1b 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 30 patients will be accrued for this study.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
January 1, 2001
Primary Completion Date
January 1, 2004
Completion Date
January 1, 2004
Last Updated
October 14, 2015
35
ACTUAL participants
recombinant interferon alpha-1b
BIOLOGICAL
IFN
DRUG
Lead Sponsor
The Cleveland Clinic
Collaborators
NCT05139017
NCT07485114
Data Source & Attribution
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