Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00031967

First received: March 8, 2002

Last updated: August 29, 2009

Last verified: March 2004

History of Changes

Tracking Information

First Received Date ^ICMJE

March 8, 2002

Last Updated Date

August 29, 2009

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00031967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Metastatic Cancer
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: therapeutic melatonin
Radiation: radiation therapy

Study Arm (s)

Publications *

Berk L, Berkey B, Rich T, Hrushesky W, Blask D, Gallagher M, Kudrimoti M, McGarry RC, Suh J, Mehta M. 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. 2007 Apr 5; [Epub ahead of print]
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00031967

Other Study ID Numbers ^ICMJE

CDR0000069245, RTOG-BR-0119, RTOG-DEV-1013

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Lawrence B. Berk, MD, PhD

Newark Radiation Oncology

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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