Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System
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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 |
- Confirmed response rate [ Designated as safety issue: No ]
- 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) |
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 |
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
Show 45 Study Locations| 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, Second Primary Central Nervous System Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes |
Pathologic Processes Nervous System Neoplasms Neoplasms by Site Nervous System Diseases Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013