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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 Identifier:
First received: December 7, 2001
Last updated: June 4, 2013
Last verified: June 2013

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 Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Biological: pegylated interferon alfa
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: May 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00027742

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)
Study Chair: Wen-Jen Hwu, MD, PhD Memorial Sloan Kettering Cancer Center
  More Information

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. Identifier: NCT00027742     History of Changes
Other Study ID Numbers: 01-005
CDR0000069062 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: December 7, 2001
Last Updated: June 4, 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:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017