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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068666
First received: September 10, 2003
Last updated: March 9, 2010
Last verified: January 2007
  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 2

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

Resource links provided by NLM:


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
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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
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, see Learn About Clinical Studies.

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

  Show 45 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
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
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:
Publications:
ClinicalTrials.gov Identifier: NCT00068666     History of Changes
Other Study ID Numbers: CDR0000327811, NCCTG-N0274
Study First Received: September 10, 2003
Last Updated: March 9, 2010
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:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Pathologic Processes
Temozolomide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014