Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC. Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients. Determine the safety profile of this drug in these patients. Determine the survival of patients treated with this drug. Determine the tumor response rate in patients treated with this drug. Determine the biological effects of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.

Official Title
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A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: poly ICLC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poly-ICLC Recurrent gliomas<br>Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC | Drug: poly ICLC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Objective Response Rate (ORR) | 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 | 2 years | 
| Percentage of Participants With Progression Free Survival | Participants evaluated from date of study entry to the 6 month scan for progression | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas | Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 2 years | 
| Overall Survival | based on date of study entry | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic astrocytoma, adult mixed glioma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult anaplastic ependymoma