Clinical trial · Interventional
Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
NCT00058123CI-TRIAL-00034488completedPhase 2Results postedClinicalTrials.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: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| poly ICLC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Poly-ICLC Recurrent gliomas
- description
- Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC
- interventionNames
- Drug: poly ICLC
Primary outcomes (2)
- measure
- Proportion of Participants With Objective Response Rate (ORR)
- timeFrame
- 2 years
- description
- Measurable: Bidimensionally measurable lesions w/ clearly defined margins by MRI Evaluable: Unidimensionally measurable lesions, masses w/margins not clearly defined. Complete Response (CR): Complete disappearance of all measurable/evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients on minimal/no steroids. Partial Response (PR): \>/= to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. Responders must be on same/decreasing doses of dexamethasone. Stable/No Response: Does not qualify for CR, PR, or progression. Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over BL if no decrease), OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). ORR = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed intracranial anaplastic glioma, including any of the following subtypes: * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Other anaplastic gliomas NOTE: Patients with an original histology of low-grade glioma are allowed provided a subsequent histological diagnosis of an anaplastic glioma is made * Must have evidence of tumor recurrence or progression by MRI or CT scan\* NOTE: \*Steroid dose must be stable for at least 5 days before scan * Prior radiotherapy required * Patients who have had prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis by positron-emission tomography, thallium scanning, magnetic resonance spectroscopy, or surgical documentation of disease * Relapsed disease * Progression after initial therapy (e.g., radiotherapy with or without chemotherapy) * No more than 3 prior therapies (initial therapy and treatment for no more than 2 prior relapses) * Surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse * For patients who have had prior therapy for a low-grade glioma, the surgical diagnosis of high-grade glioma is considered the first relapse * Must be registered in the North American Brain Tumor Consortium Data Management Center database 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 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No active infection * No concurrent serious medical illness * No significant medical illness that cannot be adequately controlled with therapy or that would preclude tolerability of study drug * No disease that would obscure toxicity or dangerously alter drug metabolism PRIOR CONCURRENT THERAPY: Biologic therapy * At least 1 week since prior interferon or thalidomide * No prior poly ICLC Chemotherapy * See Disease Characteristics * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 6 weeks since prior nitrosoureas * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 1 week since prior tamoxifen Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery * See Disease Characteristics Other * Recovered from all prior therapy * At least 1 week since other prior noncytotoxic agents (e.g., isotretinoin), excluding radiosensitizers * At least 4 weeks since prior cytotoxic therapy * At least 4 weeks since prior investigational agents
References
Publications (1)
- RESULTButowski N, Lamborn KR, Lee BL, Prados MD, Cloughesy T, DeAngelis LM, Abrey L, Fink K, Lieberman F, Mehta M, Ian Robins H, Junck L, Salazar AM, Chang SM. A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas. J Neurooncol. 2009 Jan;91(2):183-9. doi: 10.1007/s11060-008-9705-3. Epub 2008 Oct 11. PMID 18850068