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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00049361

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

11.2

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific	Drug: temozolomide Drug: thalidomide Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases

Actual Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

Dec 7, 2004

Actual Study Completion Date :

Dec 7, 2004

Outcome Measures

Primary Outcome Measures

Overall median survival []

Secondary Outcome Measures

Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter []
Median time to tumor progression []
Median time to neurologic response and progression []
Cause of death at median time []
Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter []
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Central Illinois	Decatur	Illinois	United States	62526
2	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
3	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1030
4	CCOP - Greenville	Greenville	South Carolina	United States	29615
5	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303