PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00238329|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Melanoma Melanoma (Skin)||Biological: PEG-interferon alfa-2b Drug: thalidomide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma|
|Study Start Date :||January 2001|
|Primary Completion Date :||December 2005|
|Estimated Study Completion Date :||June 2007|
- Response rate as measured scans and tumor measurements every 8 weeks
- Qualitative and quantitative toxicities at 30 days following study treatment
- Progression-free survival by standard life table and Kaplan-Meier
- Overall survival by standard life table and Kaplan-Meier
- Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks
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): 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|