NCT00032097

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2002

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

January 1, 2004

First QC Date

March 8, 2002

Last Update Submit

February 6, 2009

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Interventions

motexafin gadoliniumDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsGlioblastomaGliosarcoma

Interventions

motexafin gadoliniumRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesAstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James L. Pearlman, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Last Updated

February 9, 2009

Record last verified: 2004-01

Locations

US(1)