Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00032097

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy.

PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: motexafin gadolinium Radiation: radiation therapy	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Motexafin gadolinium Motexafin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032097

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

James L. Pearlman, MD

H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069257, NABTT-2116, JHOC-NABTT-2116
Study First Received:	March 8, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00032097 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Motexafin gadolinium
Pharmacologic Actions
Neuroectodermal Tumors

Photosensitizing Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Dermatologic Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009