Clinical trial · Interventional
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase II Trial Of Poly-ICLC For Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ
Summary
Brief summary (as posted)
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| poly ICLC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- poly-ICLC Newly diagnosed GBM
- description
- Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC
- interventionNames
- Drug: poly ICLC
Primary outcomes (1)
- measure
- Overall Survival in Pts With Newly Diagnosed GBM
- timeFrame
- 2 years
- description
- Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
Secondary outcomes (5)
- measure
- To Determine 6 Months Progression Free Survival
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN Renal * Creatinine less than 1.5 mg/dL Other * No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy * No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years * No active infection * No disease that would obscure toxicity or dangerously alter drug metabolism * No other serious concurrent medical illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior polifeprosan 20 with carmustine implant (Gliadel wafer) * No concurrent chemotherapy Endocrine therapy * Concurrent corticosteroids to treat symptoms or prevent complications are allowed Radiotherapy * No prior radiotherapy to the brain * No concurrent stereotactic radiosurgery * No concurrent brachytherapy Surgery * See Disease Characteristics Other * No prior cytotoxic or noncytotoxic drug therapy for GBM * No prior experimental drug therapy for GBM * No other concurrent cytotoxic or noncytotoxic drug therapy for GBM * Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed
References
Publications (1)
- RESULTButowski N, Chang SM, Junck L, DeAngelis LM, Abrey L, Fink K, Cloughesy T, Lamborn KR, Salazar AM, Prados MD. A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05). J Neurooncol. 2009 Jan;91(2):175-82. doi: 10.1007/s11060-008-9693-3. Epub 2008 Sep 17. PMID 18797818