Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

Completed · Phase 1/Phase 2

Conditions studied: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma

In brief

This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. 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. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.

Key facts

Study ID

NCT00305864

Run by

National Cancer Institute (NCI)

People needed

118

Starts

2006-02-09

Expected to finish

2011-03-15

Last updated by the study team

2018-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma
• Newly diagnosed by surgical biopsy or excision within the past 5 weeks
• Supratentorial location, as determined by the following:
• Contrast-enhanced MRI performed preoperatively
• MRI performed postoperatively within 28 days prior to study entry (preferably within 72 hours of surgery)
• Postoperative scan not required if diagnosed by stereotactic biopsy and pre-operative MRI was performed
• No gliomas graded < GBM
• No recurrent malignant gliomas
• No tumor foci detected below the tentorium or beyond the cranial vault
• No multifocal disease or leptomeningeal spread
• Zubrod performance status 0-1
• Neurologic function status 0-2
• Absolute neutrophil count ≥ 1,800 cells/mm\^3
• Platelet count ≥ 100,000 cells/mm\^3
• Hemoglobin ≥ 8 g/dL (transfusion allowed)
• BUN ≤ 25 mg/dL
• Creatinine ≤ 1.5 mg/dL
• Bilirubin ≤ 1.5 mg/dL
• ALT or AST ≤ 2 times upper limit of normal
• Fertile patients must use effective contraception during and for 2 months after completion of study treatment
• Negative pregnancy test
• Not pregnant or nursing
• No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ? 3 years
• No severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

Where it is running

• Arizona Oncology Services Foundation — Scottsdale, Arizona, United States
• The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Saint Rose Hospital — Hayward, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• El Camino Hospital — Mountain View, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Tumor Institute — Oakland, California, United States
• Hematology and Oncology Associates-Oakland — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Denver Veterans Administration Medical Center — Denver, Colorado, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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