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An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme


OBJECTIVES: I. Assess the safety of motexafin gadolinium and cranial irradiation, in terms
of dose-limiting toxicity and clinically significant adverse events, in patients with newly
diagnosed glioblastoma multiforme. II. Evaluate the pharmacokinetics of this regimen in
these patients. III. Determine the survival of patients treated with this regimen. IV.
Assess the activities of daily living and neurological status of patients treated with this
regimen.

OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 30
minutes on days 1-5 of weeks 1 and 2, and on days 1, 3, and 5 of weeks 3-6. Patients undergo
cranial irradiation on days 1-5 of weeks 1-6. Treatment continues in the absence of disease
progression or unacceptable toxicity. Patients undergo a neurological examination and an
activities of daily living questionnaire at baseline, week 10, and during follow-up visits.
Patients are followed at weeks 10 and 16 and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme (GBM) Grade IV
astrocytoma Located supratentorially At least 2 weeks and no more than 4 weeks since prior
surgery for GBM No recurrent disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL AST and
ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater
than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: HIV negative No
history of porphyria No glucose-6-phosphate dehydrogenase deficiency No other malignancy
within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
antineoplastic agent for GBM No concurrent chemotherapy during and for 2 weeks after study
No other concurrent antineoplastic investigational agent Endocrine therapy: Prior and
concurrent corticosteroids allowed Radiotherapy: No prior radiotherapy to the brain
Surgery: See Disease Characteristics Other: Concurrent anticonvulsants allowed Other
concurrent cancer therapy allowed if medically necessary

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Josh Yamada, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

MSKCC-01051

NCT ID:

NCT00022256

Start Date:

April 2001

Completion Date:

April 2003

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

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021