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A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme


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

Thank you

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 HopkinsBaltimore, Maryland  21231-2410