A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
OBJECTIVES:
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a
radiosensitizer in patients with glioblastoma multiforme receiving cranial
radiotherapy.
- Determine the maximum tolerated doses of this drug on these 2 schedules in these
patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the biodistribution of this drug in both neoplastic tissue and normal brain
parenchyma in these patients.
- Determine the effect and accumulation of this drug in both normal brain parenchyma and
neoplastic tissue in these patients.
- Correlate the effect and accumulation of this drug in both normal brain parenchyma and
neoplastic tissue with the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120).
Patients are sequentially assigned to 1 of 2 treatment groups.
- Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6
weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for
6 weeks.
- Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently
during radiotherapy. Patients undergo cranial radiotherapy as in group I.
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 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 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial grade IV astrocytoma
- Glioblastoma multiforme
- Previously untreated disease
- Measurable and contrast-enhancing tumor by MRI after incomplete resection/biopsy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 4 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 4 times ULN
- PT/APTT normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension
Other:
- Mini mental state exam score at least 15
- No history of glucose-6-phosphate dehydrogenase deficiency or porphyria
- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of
the breast
- No serious infection
- No other medical illness that would preclude study participation
- No allergy to MRI contrast (e.g., motexafin gadolinium)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 2 months after
study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy or immunotherapy for this disease, including any of the
following:
- Immunotoxins
- Immunoconjugates
- Antisense therapy
- Peptide receptor antagonists
- Interferons
- Interleukins
- Tumor-infiltrating lymphocytes
- Lymphokine-activated killer cell therapy
- Gene therapy
Chemotherapy:
- No prior chemotherapy for this disease
Endocrine therapy:
- Must be on a stable corticosteroid regimen (i.e., no increase within 5 days prior to
treatment on this protocol)
- No other prior hormonal therapy for this disease
Radiotherapy:
- No prior radiotherapy for this disease
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No other concurrent investigational agents
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000069257
NCT ID:
NCT00032097
Start Date:
April 2002
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 |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
