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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Melanoma; Melanoma (Skin)
• Intervention / Treatment: Drug: thalidomide; Biological: PEG-interferon alfa-2b

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201-1379
      • Barbara Ann Karmanos Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

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

Hepatic

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

Renal

• Creatinine ≤ 2 mg/dL

Cardiovascular

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

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

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

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

Surgery

• At least 28 days since prior surgery

Other

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate as measured scans and tumor measurements every 8 weeks
Qualitative and quantitative toxicities at 30 days following study treatment

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): December 1, 2005
• Study Completion: June 1, 2007

Study Registration Dates

• First Submitted: October 12, 2005
• First Submitted That Met QC Criteria: October 12, 2005
• First Posted (Estimate): October 13, 2005

Study Record Updates

• Last Update Posted (Estimate): April 8, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: 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: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Interferons; Interferon-alpha; Thalidomide; Interferon alpha-2; Peginterferon alfa-2b
• Other Study ID Numbers: CDR0000445593; P30CA022453 (U.S. NIH Grant/Contract); WSU-C-2257; WSU-HIC-120900M01-FB