Temozolomide in Treating Patients With Brain Metastases

NCT00005954 | Completed Phase 2

• 4 other identifiers: 2114DUMC-2114-02-12R3NCI-G00-1798CDR0000067934
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult tumors metastatic to brain

Interventions

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Henry S. Friedman, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: August 1, 2000
• Study Completion: June 1, 2003
• Last Updated: June 20, 2013

Record last verified: 2009-10

Locations

US (1)