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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068666

Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.

Condition	Intervention	Phase
Melanoma (Skin) Metastatic Cancer	Drug: temozolomide Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma X-Rays

Drug Information available for: Temozolomide

U.S. FDA Resources

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

Primary Outcome Measures:

Confirmed response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Change in performance status [ Designated as safety issue: No ]

Estimated Enrollment:	41
Study Start Date:	January 2004

Detailed Description:

OBJECTIVES:

Primary

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

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

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068666

Show 45 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Svetomir Markovic, MD, PhD	Mayo Clinic
Investigator:	Paul D. Brown, MD	Mayo Clinic
Investigator:	Julie E. Hammack, MD	Mayo Clinic
Investigator:	James N. Ingle, MD	Mayo Clinic
Investigator:	Edward T. Creagan, MD	Mayo Clinic
Investigator:	Judith S. Kaur, MD	Mayo Clinic
Investigator:	Evanthia Galanis, MD	Mayo Clinic
Investigator:	Charles L. Loprinzi, MD	Mayo Clinic
Investigator:	Henry C. Pitot, MD	Mayo Clinic
Investigator:	Michael K. Gornet, MD	Mayo Clinic Scottsdale
Investigator:	Ravi D. Rao, MD, MBBS	Mayo Clinic
Investigator:	Richard L. Deming, MD	Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000327811, NCCTG-N0274
Study First Received:	September 10, 2003
Last Updated:	August 29, 2009
ClinicalTrials.gov Identifier:	NCT00068666 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma
tumors metastatic to brain

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Temozolomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009