Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
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ClinicalTrials.gov Identifier: NCT00058123 |
Recruitment Status :
Completed
First Posted : April 9, 2003
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Drug: poly ICLC | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma |
Actual Study Start Date : | March 7, 2003 |
Actual Primary Completion Date : | October 6, 2007 |
Actual Study Completion Date : | January 2, 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Poly-ICLC Recurrent gliomas
Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC |
Drug: poly ICLC |
- Proportion of Participants With Objective Response Rate (ORR) [ Time Frame: 2 years ]
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
- Percentage of Participants With Progression Free Survival [ Time Frame: 6 months ]Participants evaluated from date of study entry to the 6 month scan for progression
- Number if Participants With Grade 3 and 4 Toxicities Associated With Poly-ICLC in Recurrent Gliomas [ Time Frame: 2 years ]Toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- Overall Survival [ Time Frame: 2 years ]based on date of study entry

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058123
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-6220 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Susan M. Chang, MD | University of California, San Francisco |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT00058123 |
Other Study ID Numbers: |
NABTC-0106 CDR0000287012 U01CA062399 ( U.S. NIH Grant/Contract ) NABTC-0106 |
First Posted: | April 9, 2003 Key Record Dates |
Results First Posted: | August 21, 2018 |
Last Update Posted: | August 21, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma |
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs |