Interferon Alfa in Treating Patients With Stage IV Solid Tumors, Lymphoma, or Myeloma

Phase 1

Completed

• Conditions: Melanoma; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific; Multiple Myeloma; Lymphoma; Breast Cancer; Kidney Cancer
• Interventions: Biological: recombinant interferon alpha-1b; Drug: IFN

• Registration Number: NCT00276536
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-11
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	IFN	IFN weekly
Treatment	recombinant interferon alpha-1b	IFN weekly

Primary Outcome Measures

Name	Time	Method
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	3 years

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States