Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00031967

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-05-31

Completion date

Unknown

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

unspecified adult solid tumor, protocol specific, tumors metastatic to brain, radiation toxicity

Brief summary

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

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.

Interventions

DRUGtherapeutic melatonin

RADIATIONradiation therapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

0 Years to 120 Years

Healthy volunteers

Inclusion 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 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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026