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

B

Barbara Ann Karmanos Cancer Institute

Status and phase

Completed
Phase 2

Conditions

Melanoma (Skin)
Intraocular Melanoma

Treatments

Drug: thalidomide
Biological: PEG-interferon alfa-2b

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00238329
P30CA022453 (U.S. NIH Grant/Contract)
CDR0000445593
WSU-C-2257
WSU-HIC-120900M01-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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