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Temozolomide in Treating Patients With Brain Metastases

Phase II Treatment of Adults With Brain Metastases With Temodar

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00005954
Enrollment
Unknown
Registered
2003-01-27
Start date
2000-08-31
Completion date
2003-06-30
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

adult tumors metastatic to brain

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.

Interventions

DRUGtemozolomide

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026