Breast Cancer Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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