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Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Gregory Rubino, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

UCLA-HSPC-970904303

NCT ID:

NCT00003410

Start Date:

July 1998

Completion Date:

June 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781