NCT00006039

Interferon Alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma

Phase II Study of Weekly Administered High-Dose Pegylated Interferon Alfa-2B (PEGIntron) in Advanced Stage Low Grade Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of interferon alfa-2b in treating patients who have advanced low-grade non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: I. Determine the response in patients with minimally treated or previously untreated advanced low-grade non-Hodgkin's lymphoma treated with pegylated interferon alfa-2b. II. Determine the effects of this treatment regimen on the immune system by measuring T-cell subsets and NK cells in this patient population. III. Determine event-free and progression-free survival in this patient population treated with this regimen. IV. Evaluate the toxicity profile of this treatment regimen in these patients. OUTLINE: Patients receive pegylated interferon alfa-2b subcutaneously once weekly for 6 months in the absence of disease progression or unacceptable toxicity. Upon completion of treatment, patients are followed every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 30 patients will be initially accrued for this study. Additional patients will be accrued if acceptable responses are seen in the first cohort.

Conditions

• Lymphoma
• Small Intestine Cancer

Interventions

Type	Name	Description
BIOLOGICAL	pegylated interferon alfa

Timeline

• Start date: 1999-12-01
• Primary completion: 2001-03-01
• Completion: 2001-03-01
• First posted: 2004-05-03
• Last updated: 2013-06-19

Locations

1 site across 1 country: United States