Clinical trial NCT00362817: Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases
Official title: Phase I/II Multicenter Trial of Intra-Arterial Carboplatin and Oral Temozolomide for the Treatment of Recurrent and Symptomatic Residual Brain Metastases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain Tumor
Brain Metastases
Keywords: Recurrent
Symptomatic
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2006-08-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: The primary objective of this study is to determine if chemotherapy with carboplatin and temozolomide significantly affects the response rates, or size of disease, in patients with brain metastases, originating from cancer in other parts of the body, compared to patients who have already been treated with radiation. Survival, causes of death, recurrence of disease in the central nervous system, toxicity, and quality of life will all be measured as secondary objective in this study.

Detailed description: Rationale: Surgery and radiation are often used as treatments for brain metastases, or tumors in the brain that originate from other parts of the body. It is currently unknown whether patient survival or time to progression would experience additional benefits through the addition of chemotherapy. Previous research does appear to suggest that a chemotherapy regimen may improve outcomes of patients with brain metastases previously treated with radiation. The current study further evaluates this research question by providing patients with recurrent or symptomatic residual brain metastases with carboplatin and temozolomide, two chemotherapy agents. Temozolomide has demonstrated clinical antitumor efficacy against malignant gliomas and has been tested with some efficacy against several other types of cancer. This drug appears to have less adverse effects compared to other commonly used cancer drugs. Recent research indicates that temozolomide also has some efficacy against brain metastases. In addition, previous research indicates carboplatin's lack of severe toxicity in patients with this disease.

Treatment: Study participants will be treated with carboplatin and temozolomide. Carboplatin will be administered through intravenous infusions. Temozolomide will be given through oral pills. Before these drugs are administered, study participants will undergo a pre-treatment evaluation with physical and neuropsychological examinations, neuro-imaging, laboratory tests, quality of life assessment, and other procedures. Carboplatin will be given for two consecutive days. Temozolomide will be taken by study participants daily for five consecutive days. Both of these treatment schedules will be repeated every 28 days. Several tests and exams will be given throughout the study to closely monitor patients. Study treatments will be discontinued due to disease growth or unacceptable adverse events.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed systemic cancer

Exclusion Criteria:

* Pregnant
* Known CNS meningeal involvement with cancer

Primary outcomes:
measure: Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide
timeFrame: up to 1 year
Secondary outcomes:
measure: Analyze Patients Time to Progression
timeFrame: up to 60 weeks
measure: Determine the Overall Survival of Patients
timeFrame: up to 64 weeks
measure: Determine the Cause of Death of Patients After Treatment
timeFrame: up to 1 year
measure: The Incidence and Severity of Centeral Nervous System (CNS) Toxicities
timeFrame: up to 24 weeks
measure: Quality of Life Assessment
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Herbert Newton, MD
role: PRINCIPAL_INVESTIGATOR
References: