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Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003410
First Posted: June 9, 2004
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: New imaging procedures such as the use of gadolinium texaphyrin with MRI may improve the ability to detect the extent of gliomas.

PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin used with MRI-guided surgery in treating patients with high-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: motexafin gadolinium Procedure: magnetic resonance imaging Procedure: surgical procedure Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1998
Study Completion Date: June 2004
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of gadolinium texaphyrin as a tumor retained contrast agent in MRI guided neurosurgery in patients with radiological diagnosis of high grade glioma. I. Determine the intratumoral pharmacology and quantitative pharmacokinetics of gadolinium texaphyrin using MRI imaging in these patients. II. Develop a scale that will relate MRI signal characteristics from intratumoral gadolinium texaphyrin with absolute intratumoral levels of gadolinium texaphyrin in these patients. III. Investigate the distribution of gadolinium texaphyrin in high grade gliomas in comparison with biologically active tumor as delineated by elevated choline-containing material detected by proton magnetic resonance spectroscopic imaging.

OUTLINE: This is a dose escalation study. Patients receive gadolinium texaphyrin by IV infusion 20 minutes to 2 hours prior to magnetic resonance imaging and surgery. The maximum tolerated dose for a single dose of gadolinium texaphyrin is determined by cohorts of 3 patients who are treated at one of five escalating doses. Patients in each cohort are followed for a minimum of 4 weeks each before the next cohort begins. If good contrast enhancement is assessed at the fourth dose level (cohort 4), dose escalation stops. Patients are followed at days 1 and 2, at weeks 1, 2, and 4, and at 3 months after surgery.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued into this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Radiological diagnosis of probable high grade glioma, or biopsy proven high grade glioma, undergoing neurosurgery (biopsy or tumor resection) with interactive MRI guided control Must have an enhancing cerebral lesion No radiological diagnosis of metastases due to multiple lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% while on steroids Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Prothrombin time no greater than 1.5 times upper limit of normal (ULN) Active partial thromboplastin time no greater than 1.5 times ULN Hepatic: Bilirubin no greater than 2 mg/dL AST and ALT no greater than 2 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: No other significant life threatening disease No known glucose-6-phosphate dehydrogenase deficiency or porphyria No other active malignancy No intractable seizures Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Concurrent steroids allowed Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics Other: At least 48 hours since prior MRI scan with contrast No concurrent active agent or investigational drug No concurrent use of other study treatment Concurrent antiseizure medication allowed

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003410


Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Gregory Rubino, MD Jonsson Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00003410     History of Changes
Other Study ID Numbers: UCLA-HSPC-970904303
CDR0000066422 ( Registry Identifier: PDQ (Physician Data Query) )
UCLA-HSPC-970904301
UCLA-HSPC-970904302
NCI-T97-0107
First Submitted: November 1, 1999
First Posted: June 9, 2004
Last Update Posted: June 26, 2013
Last Verified: May 2006

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Motexafin gadolinium
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents