Temozolomide in Treating Patients With Primary Brain Tumors or Metastatic Brain Tumors

NCT00547131 | Completed Phase 1

• 4 other identifiers: 05117P30CA033572CHNMC-05117CDR0000570280
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Collecting fluid samples through a catheter may help doctors find out how well temozolomide spreads throughout the brain. PURPOSE: This clinical trial is studying temozolomide in treating patients with primary brain tumors or metastatic brain tumors.

Conditions

Brain and Central Nervous System Tumors; Metastatic Cancer

Keywords

tumors metastatic to brain; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (3)

• Incidence rate of clinically symptomatic intratumoral hemorrhage

• Incidence rate of CNS infection

• Incidence rate of catheter malfunction

Secondary Outcomes (1)

• Systemic and intracerebral pharmacokinetic profile of temozolomide using a microdialysis catheter

Interventions

temozolomide DRUG

laboratory biomarker analysis OTHER

liquid chromatography OTHER

mass spectrometry OTHER

pharmacological study OTHER

conventional surgery PROCEDURE

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of a primary or metastatic brain tumor for which temozolomide would be an appropriate chemotherapy treatment postoperatively * Disease requires a debulking craniotomy or a stereotactic biopsy to diagnose or differentiate between tumor progression and treatment-induced effects after radiotherapy with or without chemotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ 2.0 mg/dL * AST ≤ 4 times upper limit of normal (ULN) * Creatinine ≤ 1.5 time ULN * Mini Mental Status Exam score ≥ 15 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy to temozolomide * No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * No concurrent chemotherapy or radiotherapy during the period of time that the microdialysis catheter is placed intracerebrally and until it is removed

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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms

Interventions

Temozolomide; Chromatography, Liquid; Mass Spectrometry; Radiosurgery

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Jana Portnow, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 22, 2007
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (2)