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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
First received: November 12, 2002
Last updated: August 20, 2009
Last verified: August 2009

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

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Overall median survival [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
  • Median time to tumor progression [ Designated as safety issue: No ]
  • Median time to neurologic response and progression [ Designated as safety issue: No ]
  • Cause of death at median time [ Designated as safety issue: No ]
  • Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days [ Designated as safety issue: Yes ]

Study Start Date: January 2004
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 4 months


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


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


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


  • 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


Biologic therapy

  • Not specified


  • 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


  • No prior radiotherapy to head or neck
  • No prior stereotactic radiosurgery
  • Concurrent radiotherapy to extracranial sites of underlying malignancy allowed


  • Prior craniotomy allowed if completed within the past 10-28 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049361

United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Wake Forest Baptist Health
National Cancer Institute (NCI)
Study Chair: Volker W. Stieber, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00049361     History of Changes
Other Study ID Numbers: CDR0000258057  CCCWFU-91102  NCI-5883 
Study First Received: November 12, 2002
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
adult tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016