Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
First received: December 7, 2001
Last updated: June 4, 2013
Last verified: June 2013

December 7, 2001
June 4, 2013
May 2001
June 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00027742 on ClinicalTrials.gov Archive Site
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Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma
A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Intraocular Melanoma
  • Melanoma (Skin)
  • Biological: pegylated interferon alfa
  • Drug: temozolomide
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
June 2005
June 2005   (final data collection date for primary outcome measure)


  • 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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
01-005, CDR0000069062, NCI-G01-2031
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Wen-Jen Hwu, MD, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP