NCT00031967
Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
PHASE2
COMPLETED
NCT00031967
INTERVENTIONAL
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.
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
Metastatic Cancer
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
- TREATMENT
-
- Type: DRUG
- Name: therapeutic melatonin
- Description:
- Arm Group Labels:
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:
- Radiation Therapy Oncology Group