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Trial record 13 of 42 for:    CT-011

Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma and Relapsed Glioblastoma Multiforme

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01952769
First received: September 15, 2013
Last updated: February 26, 2014
Last verified: September 2013
  Purpose

patients with recurrent malignant gliomas or diffuse pontine gliomas are incurable with currently used treatments. based on data stating that progressive tumors inhibit immune system, would try to enhance immune system activity and tumor cell killing. anti PD1 prevents one of the important mechanisms allowing the tumor to supress the immune system thus we hope it will allow for prolonged control of the tumors


Condition Intervention Phase
Malignant Gliomas
Biological: CT-011
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/ II Clinical Trial of CT-011 (Pidilizumab) in Diffuse Intrinsic Pontine Glioma and Relapsed Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    rate of patients with stable disease at 6 months. stable disease is defined as no change in tumor measurements on MRI greater than 20% in two diameters


Secondary Outcome Measures:
  • treatment related toxicity [ Time Frame: monthly for 1 year or if treatment will be continued further due to response-throughout treatment ] [ Designated as safety issue: Yes ]
    Treatment related toxicity according to NCI CTC Version 4.0 will be recorded monthly for 1 year or if treatment will be continued further due to response-throughout treatment. a patient with grade 3 or more treatment related toxicity will receive 50% dose reduction. if again grade 3 treatment related toxicity will occur the patient will be taken off study.


Other Outcome Measures:
  • Response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    response on imaging and neurological examination


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recurrent/resistant malignant glioma

a. progressive or recurrent pathologically confirmed high grade glioma. Note: pathological confirmation for relapse is not needed if there is pathology from primary diagnosis

intervention: CTO11 APPLICATION

Biological: CT-011
Eligible patients will be administered with CT-011 at 6.0mg/kg given as an IV infusion every other week until disease progression or a serious adverse event.
Other Name: pidilizumab
Experimental: diffuse pontine glioma
b. DIPG diagnosed based on all the following: i. Symptoms starting less than 6 weeks prior to diagnosis ii. Symptoms include one or more of the following: cranial nerve deficit, cerebellar or long tract dysfunction iii. MRI reveals a lesion infiltrating>70% of the pons
Biological: CT-011
Eligible patients will be administered with CT-011 at 6.0mg/kg given as an IV infusion every other week until disease progression or a serious adverse event.
Other Name: pidilizumab

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:3-90
  2. Diagnosis:

    1. progressive or recurrent pathologically confirmed high grade glioma. Note: pathological confirmation for relapse is not needed if there is pathology from primary diagnosis.
    2. DIPG diagnosed based on all the following:

    i. Symptoms starting less than 6 weeks prior to diagnosis ii. Symptoms include one or more of the following: cranial nerve deficit, cerebellar or long tract dysfunction iii. MRI reveals a lesion infiltrating>70% of the pons

    -

    Exclusion Criteria:

    1. grade 4 adverse event not improved by dose reduction of 50%
    2. withdrawal of informed consent
    3. disease progression
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952769

Contacts
Contact: Iris Fried, MD 97226777408 ishonet@gmail.com
Contact: Alex Lossos, MD alos@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Iris Fried, MD       ishonet@gmail.com   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01952769     History of Changes
Other Study ID Numbers: antiPD1brainad
Study First Received: September 15, 2013
Last Updated: February 26, 2014
Health Authority: Israel : Ministry of Health - Director General

Keywords provided by Hadassah Medical Organization:
anti PD1, malignant glioma. anaplastic astrocytoma.glioblastoma multiforme,diffuse pontine glioma

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 20, 2014