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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
motexafin gadolinium
magnetic resonance imaging
surgical procedure
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 25, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003410
Brief Title
Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas
Official Title
Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
motexafin gadolinium
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Intervention Type
Procedure
Intervention Name(s)
surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Rubino, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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

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