Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Completed	Not specified	NCI	RTOG-BR-0119 RTOG-DEV-1013, NCT00031967

Objectives

1. Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.

Entry Criteria

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

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

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

Expected Enrollment

A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

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.

Berk L, Berkey B, Rich T, et al.: Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119). Int J Radiat Oncol Biol Phys 68 (3): 852-7, 2007.[PUBMED Abstract]

Berk L, Seiferheld W, Rich T, et al.: RTOG BR-0119: Chronobiological study of the addition of melatonin to radiotherapy for brain metastases. [Abstract] Neuro-Oncology 6 (4): RT-01, 359, 2004.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Lawrence Berk, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 740-344-3100 Email: lbberk@radiation-oncology.com

Registry Information
Official Title		A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients
Trial Start Date		2002-05-21
Registered in ClinicalTrials.gov		NCT00031967
Date Submitted to PDQ		2002-01-24
Information Last Verified		2003-15-03
NCI Grant/Contract Number		CA21661

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