Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

February 6, 2009 updated by: Jonsson Comprehensive Cancer Center

A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin gadolinium may increase the effectiveness of radiation therapy by making tumor cells more sensitive to radiation.

PURPOSE: Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the safety and tolerability of motexafin gadolinium in combination with radiotherapy in patients with newly diagnosed glioblastoma multiforme. II. Determine the intratumoral pharmacology and quantitative pharmacokinetics of this drug in this patient population.

OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium. Patients receive a loading dose regimen comprising motexafin gadolinium IV over 10-15 minutes on days 1-5 or days 1-5 and 8-12 (cohort 7). After the loading dose regimen, patients receive a maintenance regimen comprising motexafin gadolinium IV 3 times weekly for a maximum of 6.5 weeks. Patients also undergo radiotherapy once daily, 5 days a week, for 6.5 weeks. Cohorts of 3-6 patients receive an escalating number of doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme requiring radical radiotherapy No anaplastic astrocytoma or low-grade astrocytoma Able to start radiotherapy within 5 weeks of definitive surgery (unless delay due to cause other than medical illness or poor performance status)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Karnofsky 60-100% 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 Hepatic: AST and ALT no greater than 2 times upper limit of normal (ULN) Bilirubin no greater than 2 mg/dL PT and aPTT no greater than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe lung disease Other: No other significant life-threatening disease No other active malignancy No known glucose-6-phosphate dehydrogenase deficiency No known porphyria Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No biologic therapy for at least 4 weeks after study completion No immunotherapy for at least 4 weeks after study completion Chemotherapy: No chemotherapy for at least 4 weeks after study completion Endocrine therapy: Concurrent steroids allowed Radiotherapy: See Disease Characteristics No prior radiotherapy for this disease or other brain tumor No prior radiotherapy to face, head, or neck Surgery: See Disease Characteristics Recovered from prior surgery or postoperative complication Other: At least 48 hours since prior MRI scan with contrast No concurrent MRI scans with contrast No other concurrent experimental drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Judith M. Ford, MD, PhD, Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

December 1, 2003

First Posted (Estimate)

December 2, 2003

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066421
  • UCLA-HSPC-970904203
  • COOPER-RP-97-126
  • LAC-USC-6G971
  • UCD-RW-98-01
  • UCLA-HSPC-970904201
  • UCLA-HSPC-970904202
  • NCI-T97-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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