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

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


- 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

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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Not specified


- Creatinine no greater than 1.7 mg/dL

- BUN no greater than 2 times upper limit of normal


- No uncontrolled hypertension

- No unstable angina pectoris

- No uncontrolled cardiac dysrhythmia


- 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


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)


- 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


- See Disease Characteristics

- No concurrent radiosurgery


- See Disease Characteristics

- See Radiotherapy


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Larry Kleinberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • recurrent adult brain tumor
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Abramson Cancer Center at University of Pennsylvania Medical Center Philadelphia, Pennsylvania  19104