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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA062399 | U.S. NIH Grant/Contract | View source | |
| NABTC-0106 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poly-ICLC Recurrent gliomas | Experimental | Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| poly ICLC | Drug |
|
| 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 |
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed intracranial anaplastic glioma, including any of the following subtypes:
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
Relapsed disease
Must be registered in the North American Brain Tumor Consortium Data Management Center database
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Susan M. Chang, MD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States | ||
| UCSF Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18850068 | Result | Butowski 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. |
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55 patients enrolled between 7/14/2003 and 12/192005 at Outpatient Clinical Centers
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| ID | Title | Description |
|---|---|---|
| FG000 | Poly-ICLC Recurrent Gliomas | Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection poly ICLC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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based on date of study entry
| 2 years |
| San Francisco |
| California |
| 94115 |
| United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15232 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-6220 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
55 enrolled however, 10 were not evaluable for outcomes
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| ID | Title | Description |
|---|---|---|
| BG000 | Poly-ICLC Recurrent Gliomas | Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection poly ICLC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Karnofsky Performance Status Scale | Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death | Median | Full Range | units on a scale |
| |||||||||||||||||||||
| Histology | WHO Classification | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Progression Free Survival | Participants evaluated from date of study entry to the 6 month scan for progression | Posted | Number | percentage of participants | 6 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | based on date of study entry | Survival time was known for all 45 patients and 13 patients were censored as they were alive at last contact | Posted | Median | 95% Confidence Interval | weeks | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Poly-ICLC Recurrent Gliomas | Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection poly ICLC | 0 | 45 | 0 | 45 | 45 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Elevated Alanine Transferase | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Granulocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Lymphocytopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Chang, MD | North American Brain Tumor Consortium | 410-955-8837 | jfisher@jhmi.edu |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| D001932 | Brain Neoplasms |
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C019531 | poly ICLC |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| Anaplastic Mixed Oligoastrocytoma |
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
| Dyspnea |
| |||||
| Elevated Alanin Aminotransferase |
| |||||
| Hypoxia |
| |||||
| Leukopenia |
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| Muscle Weakness |
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| Elevated Sodium |
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| Tremors |
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| Title | Denominators | Categories |
|---|
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