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

• Status: Completed
• Trial end date: 2004-12-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dacarbazine; Temozolomide; Thalidomide

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

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No other concurrent chemotherapy during and for 4 weeks after study

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to head or neck

• No prior stereotactic radiosurgery

• Concurrent radiotherapy to extracranial sites of underlying malignancy allowed

Surgery

• Prior craniotomy allowed if completed within the past 10-28 days