Brachytherapy in Treating Patients With Recurrent Malignant Glioma

NCT00045474 | Completed Phase 1

• 3 other identifiers: CDR0000256587NABTT-2106JHOC-NABTT-2106
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery. PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Interventions

adjuvant therapy PROCEDURE

iodine I 125 RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme * Low-grade astrocytoma that progresses to high-grade astrocytoma allowed * Unifocal disease * Progressive or recurrent after radiotherapy with or without chemotherapy * Previously treated with at least 5,000 cGy external beam radiotherapy more than 3 months ago * Candidate for maximal surgical resection * Any expected residual enhancing tumor must be within expected brachytherapy treatment volume * Resection must not be expected to result in a new permanent neurologic deficit * No tumor crossing more than 1 cm beyond the midline on preoperative MRI or CT scan * No grossly or radiographically apparent leptomeningeal spread * No ventricular invasion outside the anticipated radiotherapy treatment volume * No marked edema on MRI or CT scan * Patients with 2 or more separate foci of contrast-enhancing tumors that are more than 5 cm apart on preoperative MRI or CT scan are ineligible 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 * Platelet count at least 100,000/mm\^3 Hepatic * Not specified Renal * Creatinine no greater than 1.7 mg/dL * BUN no greater than 2 times upper limit of normal Cardiovascular * No uncontrolled hypertension * No unstable angina pectoris * No uncontrolled cardiac dysrhythmia Other * Mini mental score at least 15 * No other medical illness that would preclude study participation * No serious infection * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy * No concurrent biologic agents (e.g., immunotoxins, immunoconjugates, antiangiogenesis compounds, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * No concurrent polifeprosan 20 with carmustine implant (Gliadel wafer) Endocrine therapy * Concurrent corticosteroids allowed to improve quality of life Radiotherapy * See Disease Characteristics * No concurrent radiosurgery Surgery * See Disease Characteristics * See Radiotherapy Other * Recovered from prior therapy * No prior investigational agents * No investigational agents during and for 90 days after study participation * Concurrent cytotoxic treatment allowed to improve quality of life

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3295, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

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

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

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

Interventions

Chemotherapy, Adjuvant; Iodine-125

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Larry Kleinberg, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Last Updated: February 9, 2009

Record last verified: 2003-04

Locations

US (9)