Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma (IFNa)
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|ClinicalTrials.gov Identifier: NCT00276536|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : October 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Kidney Cancer Lymphoma Melanoma Multiple Myeloma Sarcoma Unspecified Adult Solid Tumor, Protocol Specific||Biological: recombinant interferon alpha-1b Drug: IFN||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Evaluation of Interferon-alpha-1b in Solid Tumors, Lymphoma or Myeloma|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
Biological: recombinant interferon alpha-1b
Other Name: Interferon
Other Name: Interferon
- Tolerance and safety as measured by any ≥ Grade IV granulocyte toxicity or any Grade III toxicity thought to be drug related at 1 week after each course [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276536
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195-5044|
|Study Chair:||Ernest C. Borden, MD||The Cleveland Clinic|