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A Phase I Trial to Evaluate Repetitive Intravenous Doses of Gadolinium-Texaphyrin as a Radiosensitizer in Patients With Glioblastoma Multiforme

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase I Trial to Evaluate Repetitive Intravenous Doses of Gadolinium-Texaphyrin as a Radiosensitizer in Patients With Glioblastoma Multiforme

OBJECTIVES: I. Evaluate the toxic effects of gadolinium texaphyrin administered to patients
receiving cranial radiotherapy for glioblastoma multiforme. II. Determine the maximum
tolerated dose of this regimen in these patients. III. Determine the pharmacokinetic profile
of this regimen in these patients. IV. Determine the biodistribution of gadolinium
texaphyrin in both neoplastic tissue and normal brain parenchyma. V. Evaluate the effect and
accumulation of this regimen in normal brain parenchyma and neoplastic tissue by following
the change in enhancing volume and percent change in signal intensity over time.

OUTLINE: This is an open label, multicenter study. Arm I: Patients receive radiotherapy once
a day, 5 days a week, for 6 weeks. Gadolinium texaphyrin IV is administered every other day
within 2-5 hours prior to radiotherapy. Patients are evaluated at 1 month, and if no more
than 1 of 3 patients experiences unacceptable toxicity, 3 patients are entered on the
imaging portion of the study. Once arm I has successfully entered 3 patients with acceptable
toxicity profiles and 3 patients in the imaging portion of the study, patient enrollment
begins for arm II. Arm II: Cohorts of 3-9 patients receive radiotherapy as in arm I and
escalating doses of gadolinium texaphyrin IV administered within 2-5 hours prior to each
radiation dose. The maximum tolerated dose (MTD) of gadolinium texaphyrin is defined as the
dose at which no more than one third of the patients experience dose limiting toxicity. Arm
III: Patients experiencing dose limiting toxicity in arm II requiring dose reduction below
predetermined once a day limit receive gadolinium every other day, with radiotherapy as in
arm II. The MTD is defined as in arm II. Arm IV: An additional 3 patients are enrolled at
the MTD and enter the imaging portion of the study. Patients are followed for 1 month after
final radiation therapy.

PROJECTED ACCRUAL: At least 18 patients will be accrued for this study within 6 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated, supratentorial
grade IV glioblastoma multiforme Measurable and contrast enhancing disease on
postoperative MRI

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count
at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL
Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 4 times
upper limit of normal (ULN) SGOT or SGPT no greater than 4 times ULN PT and aPTT normal
Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile
patients must use effective contraception Negative pregnancy test No serious infection or
medical illness No history of glucose-6-phosphate dehydrogenase deficiency No known
porphyria No other prior malignancy within the past 5 years except curatively treated
basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for glioblastoma
multiforme No prior immunotoxins, immunoconjugates, antisense, peptide receptor
antagonists, interferons, interleukins, tumor infiltrating lymphocytes, lymphokine
activated killer cells, or gene therapy for glioblastoma multiforme Chemotherapy: No prior
chemotherapy for glioblastoma multiforme Endocrine therapy: No prior hormonal therapy for
glioblastoma multiforme Stable corticosteroid regimen for at least 5 days prior to study
Radiotherapy: No prior radiotherapy for glioblastoma multiforme Surgery: Recovered from
postoperative complications Other: No other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James L. Pearlman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:

NABTT-9712 CDR0000066986



Start Date:

April 1999

Completion Date:

March 2004

Related Keywords:

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