Brachytherapy in Treating Patients With Recurrent Malignant Glioma

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

Sponsoren

Hauptsponsor: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum October 2002
Phase Phase 1
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: adjuvant therapy

Interventionsart: Radiation

Interventionsname: iodine I 125

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Larry Kleinberg, MD Study Chair Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Ort
Einrichtung:
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama, 35294-3295, United States
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida, 33612-9497, United States
Winship Cancer Institute of Emory University | Atlanta, Georgia, 30322, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland, 21231-2410, United States
Massachusetts General Hospital Cancer Center | Boston, Massachusetts, 02114, United States
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan, 48202, United States
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina, 27157-1030, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
Abramson Cancer Center at University of Pennsylvania Medical Center | Philadelphia, Pennsylvania, 19104-4283, United States
Standort Länder

United States

Überprüfungsdatum

April 2003

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Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov