Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Conditions

Brain and Central Nervous System Tumors

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: temozolomide

Drug: thalidomide

Radiation: radiation therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00049361

CCCWFU-91102

REBACDR0000258057

NCI-5883

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.

Full description

OBJECTIVES:

Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.
Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.
Determine the cause of death of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Assess quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.

Patients are followed at 1 and 3 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically confirmed extracranial primary malignancy or brain metastases
At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI
No evidence of spinal drop metastases or spread to noncontiguous meninges
No lymphoma, small cell lung cancer, or germ cell tumor

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

At least 4 months

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic

Bilirubin less than 1.5 mg/dL
SGPT and/or SGOT no greater than 2 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL
BUN no greater than 25 mg/dL

Other

Able to be regularly followed
No sensory neuropathy greater than grade 2
No other major medical illnesses that would preclude study
No neurologic or psychiatric impairments that would preclude study
No active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy