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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
poly ICLC
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult mixed glioma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult anaplastic ependymoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • UCSF Comprehensive Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • M.D. Anderson Cancer Center at University of Texas
  • University of Texas Health Science Center at San Antonio
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Poly-ICLC Recurrent gliomas

Arm Description

Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday) Intramuscular injection Drug Poly-ICLC

Outcomes

Primary Outcome Measures

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
Percentage of Participants With Progression Free Survival
Participants evaluated from date of study entry to the 6 month scan for progression

Secondary Outcome Measures

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
Overall Survival
based on date of study entry

Full Information

First Posted
April 7, 2003
Last Updated
July 24, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058123
Brief Title
Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Official Title
A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 7, 2003 (Actual)
Primary Completion Date
October 6, 2007 (Actual)
Study Completion Date
January 2, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic astrocytoma, adult mixed glioma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult anaplastic ependymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M. Chang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-6220
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18850068
Citation
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.
Results Reference
result

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

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