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PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00238329•Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•DISEASE CHARACTERISTICS:
•Histologically confirmed malignant melanoma, including any of the following:
•* Cutaneous melanoma
•* Ocular melanoma
•* Mucosal melanoma
•* Unidentified primary tumor
•Recurrent or metastatic disease
•Bidimensionally measurable or evaluable disease
•Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy
•PATIENT CHARACTERISTICS:
+39 more criteria

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

January 1, 2001

Primary Completion Date

December 1, 2005

Completion Date

June 1, 2007

Last Updated

April 8, 2013

Enrollment

ESTIMATED participants

Conditions

Intraocular MelanomaMelanoma (Skin)

Interventions

PEG-interferon alfa-2b

BIOLOGICAL

thalidomide

DRUG

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

NCT07136181

Metastatic Uveal MelanomaUveal Melanoma, Metastatic+3 more

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RECRUITINGPHASE3

Adjuvant Melatonin for Uveal Melanoma

NCT05502900

Uveal MelanomaUveal Melanoma, Posterior, Medium/Large Size+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Adjuvant Melatonin for Uveal Melanoma

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