Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045474
• Other study ID #: CDR0000256587
• Secondary ID: NABTT-2106JHOC-N
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2002
• Last updated: February 6, 2009
• Start date: October 2002

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma.

• Determine the acute and chronic toxicity of this therapy in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.

Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks and then every 2 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Procedure:
• adjuvant therapy

Radiation:
• iodine I 125

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,