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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058123
Recruitment Status : Completed
First Posted : April 9, 2003
Results First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE April 7, 2003
First Posted Date  ICMJE April 9, 2003
Results First Submitted Date  ICMJE October 14, 2016
Results First Posted Date  ICMJE August 21, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE March 7, 2003
Actual Primary Completion Date October 6, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma
Official Title  ICMJE A Phase II Trial of Poly ICLC in Patients With Recurrent Anaplastic Glioma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE Drug: poly ICLC
Study Arms  ICMJE Experimental: Poly-ICLC Recurrent gliomas

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

Intramuscular injection

Drug Poly-ICLC

Intervention: Drug: poly ICLC
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2018)
55
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2, 2009
Actual Primary Completion Date October 6, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00058123
Other Study ID Numbers  ICMJE NABTC-0106 CDR0000287012
U01CA062399 ( U.S. NIH Grant/Contract )
NABTC-0106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Susan M. Chang, MD University of California, San Francisco
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP