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PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
This study is ongoing, but not recruiting participants.
First Received: October 12, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00238329
  Purpose

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 Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: PEG-interferon alfa-2b
Drug: thalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured scans and tumor measurements every 8 weeks [ Designated as safety issue: No ]
  • Qualitative and quantitative toxicities at 30 days following study treatment [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
  • Overall survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
  • Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2001
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238329

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000445593, WSU-C-2257, WSU-HIC-120900M01-FB
Study First Received: October 12, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00238329     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
iris melanoma
recurrent intraocular melanoma

Study placed in the following topic categories:
Anti-Infective Agents
Uveal Melanoma
Thalidomide
Immunologic Factors
Melanoma of the Choroid
Melanoma
Anti-Bacterial Agents
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Interferon-alpha
Eye Neoplasms
Eye Diseases
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Recurrence
Neuroendocrine Tumors
Neuroectodermal Tumors
Intraocular Melanoma
Peginterferon alfa-2b
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Bacterial Agents
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon-alpha
Neoplasms by Histologic Type
Eye Neoplasms
Growth Substances
Eye Diseases
Interferons
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Peginterferon alfa-2b
Interferon Alfa-2a
Interferon Alfa-2b

ClinicalTrials.gov processed this record on September 11, 2009