Immunotoxin Therapy in Treating Patients With Malignant Glioma

NCT00006268 | Completed Phase 1

• 5 other identifiers: CDR0000068211NABTT-9903JHOC-NABTT-9903NEOPHARM-TS-G1-TI4NEOPHARM-IL13PEI-001-R03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 11

Brief Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

cintredekin besudotox BIOLOGICAL

isolated perfusion DRUG

conventional surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically proven malignant glioma (grade 3 or 4) * Anaplastic astrocytoma * Glioblastoma multiforme * Malignant mixed oligoastrocytoma * Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study * Must have undergone supratentorial brain tumor surgery or biopsy * Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study * Must have solid portion measuring 1.0-5.0 cm in maximum diameter * Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm * No tumor crossing the midline * No leptomeningeal tumor dissemination * No impending herniation or spinal cord compression * No uncontrolled seizures PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 10 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * PT and PTT no greater than upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times ULN * Bilirubin no greater than 2.0 mg/dL Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior intralesional chemotherapy for malignant glioma * At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered * No concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study Radiotherapy: * See Disease Characteristics * No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma Surgery: * See Disease Characteristics Other: * Recovered from any prior therapy * No other concurrent investigational agent

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

Sponsors & Collaborators

• New Approaches to Brain Tumor Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (11)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

National Institute of Neurological Disorders and Stroke

Bethesda, Maryland, 20892-1414, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms; Glioblastoma; Astrocytoma; Glioma; Gliosarcoma

Interventions

IL13-PE38

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jon Weingart, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 2000
• Study Completion: March 1, 2005
• Last Updated: June 24, 2013

Record last verified: 2005-03

Locations

US (11)