Know Cancer

or
forgot password

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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Judith M. Ford, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066421

NCT ID:

NCT00003409

Start Date:

July 1998

Completion Date:

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of California Davis Cancer CenterSacramento, California  95817