Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NCCTG-N0274 N0274, NCT00068666

Objectives

Primary

1. Determine the response rate in patients with stage IV malignant melanoma with measurable and unresectable disease of the central nervous system treated with temozolomide and radiotherapy.

Secondary

1. Determine the safety of this regimen in these patients.
2. Determine the survival of patients treated with this regimen.
3. Determine the effect of this regimen on performance status and mental status of these patients.
4. Determine the response of extra-cranial disease in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS)
  • Study entry within 14 days of diagnosis of brain metastases



• Recursive partitioning analysis class I or II



• Disease for which no known standard therapy exists that is potentially curative or proven capable of extending life expectancy



• No meningeal carcinomatosis based on imaging studies or on positive results from CSF analysis



• No evidence of metastatic disease outside of the CNS

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior biologic therapy
• More than 4 weeks since prior immunotherapy

Chemotherapy

• No prior temozolomide
• More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy

• Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging

Radiotherapy

• More than 4 weeks since prior radiotherapy
• No prior radiotherapy to more than 15% of the bone marrow
• No prior radiotherapy to the head and neck area
• No prior radiosurgery

Surgery

• See Radiotherapy

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL

Hepatic

• AST no greater than 3 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 3 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No concurrent uncontrolled infection
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
• No prior allergy or intolerance to dacarbazine
• No hypersensitivity to temozolomide or any of its components

Expected Enrollment

A total of 18-41 patients will be accrued for this study within 13-30 months.

Outcomes

Confirmed response rate

Progression-free survival
Overall survival
Change in performance status

Outline

Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Svetomir Markovic, MD, PhD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Paul Brown, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Julie Hammack, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
James Ingle, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Edward Creagan, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Judith Kaur, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Evanthia Galanis, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Charles Loprinzi, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Henry Pitot, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Michael Gornet, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Ravi Rao, MD, MBBS, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Richard Deming, MD, Protocol co-chair		Ph: 515-643-8780 Email: rdeming@mercydesmoines.org

Registry Information
Official Title		A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
Trial Start Date		2004-01-09
Registered in ClinicalTrials.gov		NCT00068666
Date Submitted to PDQ		2003-08-04
Information Last Verified		2007-01-12
NCI Grant/Contract Number		CA25224

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