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Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV 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: NCT00027742
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Melanoma (Skin) Biological: pegylated interferon alfa Drug: temozolomide Phase 2

Detailed Description:


  • Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa.
  • Determine the toxicity profile of this regimen in these patients.
  • Determine the duration of disease response and overall survival of patients treated with this regimen.

OUTLINE: Patients are stratified according to CNS metastases (yes vs no).

Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma
Study Start Date : May 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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

    • Unresectable stage III or stage IV disease
    • Ocular, mucosal, or cutaneous melanoma
  • Measurable disease



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min


  • No history of severe cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No New York Heart Association class III or IV heart disease (congestive heart failure)
  • No ventricular tachyarrhythmias


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No AIDS-related illness
  • No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
  • No serious infection requiring IV antibiotics
  • No psychiatric disorder requiring ongoing therapy or medication
  • No nonmalignant illness or other medical condition that would preclude study
  • No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP


Biologic therapy:

  • At least 4 weeks since prior biologic therapy or immunotherapy and recovered
  • No concurrent immunotherapy


  • No prior dacarbazine
  • No prior temozolomide
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids


  • At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery
  • At least 3 weeks since prior radiotherapy to the brain for brain metastases
  • Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy


  • At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered

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): NCT00027742

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Wen-Jen Hwu, MD, PhD Memorial Sloan Kettering Cancer Center
Publications of Results:
Krown SE, Hwu WJ, Menell JH, et al.: A phase II study of temozolomide (TMZ) and pegylated interferon α-2b (PGI) in the treatment of advanced melanoma. [Abstract] J Clin Oncol 22 (Suppl 14): A-7533, 718s, 2004.

Layout table for additonal information Identifier: NCT00027742    
Other Study ID Numbers: 01-005
CDR0000069062 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
iris melanoma
extraocular extension melanoma
recurrent intraocular melanoma
stage III melanoma
stage IV melanoma
recurrent 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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs