Clinical trial · Interventional
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
NCT00053183CI-TRIAL-00002005completedPhase 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: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Clinically suspected supratentorial grade IV glioblastoma multiforme * Candidate for maximal surgical resection of tumor mass * Expected residual enhancing tumor must be within the expected brachytherapy treatment volume * Resection must not be expected to result in a new permanent neurologic deficit * No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI) * No enhancing tumor greater than 1 cm beyond the midline by MRI * No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume * No marked edema by MRI with significant shift that is not anticipated to be corrected by resection 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 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Mini mental state exam score at least 15 * No other concurrent medical illness that would preclude study participation * No concurrent serious infection * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No immunotherapy prior to, during, or within 90 days after brachytherapy * No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : * Immunotoxins * Immunoconjugates * Antiangiogenesis compounds * Peptide receptor antagonists * Interferons * Interleukins * Tumor-infiltrating lymphocytes * Lymphokine-activated killer cells * Gene therapy * Antisense agents Chemotherapy * No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy Endocrine therapy * No hormonal therapy prior to, during, or within 90 days after brachytherapy * Concurrent corticosteroids to improve quality of life allowed Radiotherapy * No other radiotherapy prior to, during, or within 90 days after brachytherapy Surgery * See Disease Characteristics * No radiosurgery prior to, during, or within 90 days after brachytherapy Other * No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy * Concurrent noncytotoxic therapy to improve quality of life allowed
References
Publications (0)
Data not yet available
No reference posted for this study.