Brachytherapy in Treating Patients With Recurrent Malignant Glioma

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Brain and Central Nervous System Tumors

Treatments

Procedure: adjuvant therapy

Radiation: iodine I 125

Study type

Interventional

Funder types

NIH

Identifiers

NCT00045474

CDR0000256587

NABTT-2106

JHOC-NABTT-2106

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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