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

NCT ID: NCT00049361

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2004-12-07

Brief 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.

Detailed 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.

Conditions

Brain and Central Nervous System Tumors; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

temozolomide

Intervention Type: DRUG

thalidomide

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker W. Stieber, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-91102

Identifier Type: -

Identifier Source: secondary_id

NCI-5883

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000258057

Identifier Type: -

Identifier Source: org_study_id