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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238329
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : April 8, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Melanoma (Skin) Biological: PEG-interferon alfa-2b Drug: thalidomide Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
Study Start Date : January 2001
Actual Primary Completion Date : December 2005
Study Completion Date : June 2007

Primary Outcome Measures :
  1. Response rate as measured scans and tumor measurements every 8 weeks
  2. Qualitative and quantitative toxicities at 30 days following study treatment

Secondary Outcome Measures :
  1. Progression-free survival by standard life table and Kaplan-Meier
  2. Overall survival by standard life table and Kaplan-Meier
  3. Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • SWOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT ≤ 2 times ULN


  • Creatinine ≤ 2 mg/dL


  • None of the following conditions within the past 3 months:

    • Congestive heart failure
    • Second- or third-degree heart block
    • Myocardial infarction


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
  • No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
  • No concurrent blood, sperm, or ova donation


Biologic therapy

  • Prior biologic therapy (e.g., interferon) allowed


  • Not specified

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 28 days since prior radiotherapy


  • At least 28 days since prior surgery


  • No more than 2 prior systemic treatment regimens for metastatic malignant melanoma

Information from the National Library of Medicine

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 identifier (NCT number): NCT00238329

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Barbara Ann Karmanos Cancer Institute Identifier: NCT00238329    
Other Study ID Numbers: CDR0000445593
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent melanoma
stage IV melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
recurrent intraocular melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors