Clinical trial · Interventional
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
NCT00045474CI-TRIAL-00001994completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| iodine I 125 | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 lifeReferences
Publications (0)
Data not yet available
No reference posted for this study.