Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy. PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.

Detailed Description
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OBJECTIVES: Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning. Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening. All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

Official Title
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A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients

Conditions
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Metastatic Cancer, Radiation Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: therapeutic melatonin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed solid tumor with brain metastasis No germ cell tumors RPA class II with any of the following: At least 65 years of age Extracranial metastases Uncontrolled primary malignancy Ineligible for or unwilling to participate in alternative RTOG stereotactic radiosurgery studies PATIENT CHARACTERISTICS: Age: See Disease Characteristics Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to swallow pills Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: More than 30 days since prior chemotherapy Concurrent chemotherapy after whole brain irradiation allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the brain Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: therapeutic melatonin|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, tumors metastatic to brain, radiation toxicity