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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: therapeutic melatonin
• Procedure: radiation therapy

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Radiation Therapy Oncology Group

Overall Clinical Trial Officials and Contacts

Lawrence B. Berk, MD, PhD Study Chair Newark Radiation Oncology  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00031967

Study ID Number: CDR0000069245

ClinicalTrials.gov Identifier: NCT00031967

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database