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Temozolomide in Treating Patients With Brain Metastases

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
Sponsored by
Duke University
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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Metastatic lesions to the brain Must not require immediate radiotherapy If received prior radiotherapy, must have progressive disease Evaluable disease by CT scan or MRI Neurologically stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks 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 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Blood urea nitrogen less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent nonmalignant systemic disease No acute infection requiring treatment with IV antibiotics HIV negative No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors, including epoetin alfa No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy, unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: No other concurrent investigational drugs

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
June 19, 2013
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005954
Brief Title
Temozolomide in Treating Patients With Brain Metastases
Official Title
Phase II Treatment of Adults With Brain Metastases With Temodar
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.
Detailed Description
OBJECTIVES: Determine the activity of temozolomide in patients with brain metastases. Determine the toxicity of this treatment in these patients. OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other). Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

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
Keywords
adult tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Metastatic lesions to the brain Must not require immediate radiotherapy If received prior radiotherapy, must have progressive disease Evaluable disease by CT scan or MRI Neurologically stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: More than 12 weeks 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 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Blood urea nitrogen less than 1.5 times ULN Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent nonmalignant systemic disease No acute infection requiring treatment with IV antibiotics HIV negative No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors, including epoetin alfa No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy, unless evidence of disease progression No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression No concurrent radiotherapy Surgery: At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry S. Friedman, MD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Temozolomide in Treating Patients With Brain Metastases

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