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NCT Number: NCT00031967

Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

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.

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Key information

Conditions

Metastatic Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Unspecified Adult Solid Tumor, Protocol Specific Wounds and Injuries

Age range

0 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic melatonin

Drug

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2002
Primary completion: 2004
First posted: Jan 27, 2003
Registry last updated: Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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