Clinical Trials Directory

Trials / Completed

CompletedNCT00238329

PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (estimated)
Sponsor
Barbara Ann Karmanos Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.

Detailed description

OBJECTIVES: * Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide. * Determine the quantitative and qualitative toxic effects of this regimen in these patients. * Determine progression-free and overall survival of patients treated with this regimen. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPEG-interferon alfa-2b
DRUGthalidomide

Timeline

Start date
2001-01-01
Primary completion
2005-12-01
Completion
2007-06-01
First posted
2005-10-13
Last updated
2013-04-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00238329. Inclusion in this directory is not an endorsement.