Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme

NCT00006452 | Completed Phase 1

• 4 other identifiers: NABTT-9712 CDR0000066986P30CA006973NABTT-9712JHOC-NABTT-9712
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

motexafin gadolinium DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated, supratentorial grade IV glioblastoma multiforme Measurable and contrast enhancing disease on postoperative MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 4 times upper limit of normal (ULN) SGOT or SGPT no greater than 4 times ULN PT and aPTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No serious infection or medical illness No history of glucose-6-phosphate dehydrogenase deficiency No known porphyria No other prior malignancy within the past 5 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for glioblastoma multiforme No prior immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, tumor infiltrating lymphocytes, lymphokine activated killer cells, or gene therapy for glioblastoma multiforme Chemotherapy: No prior chemotherapy for glioblastoma multiforme Endocrine therapy: No prior hormonal therapy for glioblastoma multiforme Stable corticosteroid regimen for at least 5 days prior to study Radiotherapy: No prior radiotherapy for glioblastoma multiforme Surgery: Recovered from postoperative complications 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

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

motexafin gadolinium; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, 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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: March 8, 2004
• Study Start: April 10, 2002
• Primary Completion: May 9, 2003
• Study Completion: March 16, 2004
• Last Updated: June 27, 2018

Record last verified: 2018-06