Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CCCWFU-91102 NCI-5883, NCT00049361, 5883

Objectives

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

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Overall median survival

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Volker Stieber, MD, Protocol chair		Ph: 336-713-6560; 800-446-2255 Email: vstieber@wfubmc.edu

Registry Information
Official Title		A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
Trial Start Date		2004-01-02
Registered in ClinicalTrials.gov		NCT00049361
Date Submitted to PDQ		2002-09-11
Information Last Verified		2005-12-28
NCI Grant/Contract Number		CA12197, CA81851

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