PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
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.
Biological: PEG-interferon alfa-2b
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma|
- Response rate as measured scans and tumor measurements every 8 weeks [ Designated as safety issue: No ]
- Qualitative and quantitative toxicities at 30 days following study treatment [ Designated as safety issue: Yes ]
- Progression-free survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
- Overall survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
- Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks [ Designated as safety issue: No ]
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||June 2007|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238329
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Principal Investigator:||Ulka N. Vaishampayan, MD||Barbara Ann Karmanos Cancer Institute|