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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
thalidomide
radiation therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CCOP - Central Illinois
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • CCOP - Greenville
  • CCOP - Upstate Carolina

Outcomes

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

Full Information

First Posted
November 12, 2002
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00049361
Brief Title
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
Official Title
A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
December 7, 2004 (Actual)
Study Completion Date
December 7, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Drug
Intervention Name(s)
thalidomide
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall median survival
Secondary Outcome Measure Information:
Title
Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter
Title
Median time to tumor progression
Title
Median time to neurologic response and progression
Title
Cause of death at median time
Title
Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter
Title
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker W. Stieber, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1030
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

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

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