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Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma

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ClinicalTrials.gov Identifier: NCT01952769
Recruitment Status : Unknown
Verified October 2015 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2013
Last Update Posted : September 13, 2016
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
DIPG Biological: MDV9300 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/ II Clinical Trial of MDV9300 (Pidilizumab) in Diffuse Intrinsic Pontine Glioma
Study Start Date : February 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: treatment of DIPG with MDV9300
treatment of diffuse pontine glioma with MDV9300 with the combination of radiation and low dose cyclophosphamide
Biological: MDV9300

The study will be done in the following manner:

  1. Evaluation of MDV9300 and radiation-

    1. Cohort A-3 patients: first dose of MDV9300 3mg/m2 .If no toxicity over grade 2-second dose and on -6 mg/kg.
    2. Cohort B -3 patiens: if no toxicity >grade 2 seen in cohort A- start dose will be 6 mg/kg If toxicity> grade 2 in 2 patients or more on a dose of 3 mg/kg the dose in cohort B will be 1 mg/kg during irradiation If toxicity> grade 2 in 2 patients or more on a dose of 1 mg/kg no further concurrent MDV9300 and radiation will be given
  2. Evaluation of MDV9300 and cyclophosphamide

After completion of the first phase (6 patients) a cohort of 15 patients will be accrued. The treatment protocol of this cohort will be as follows:

Following radiation completion , and after recovery from treatment adverse events of grade 2 and higher, the patients will be started on concurrent biweekly MDV9300 and weekly cyclophosphamide 200mg/m2

Other Name: pidilizumab

Primary Outcome Measures :
  1. treatment related toxicity [ Time Frame: monthly for 1 year or if treatment will be continued further due to response-throughout treatment ]
    Treatment related toxicity according to NCI CTC Version 4.0 will be recorded 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.

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]
    tumor measurements according to RANO criteria will be recorded

Other Outcome Measures:
  1. overall survival [ Time Frame: 6 months ]
    survival after 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Age: 3-21
  2. Diagnosis:

    a. 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

  3. patient status:

    1. karnofsky or lansky (for children) scale of 60 or more (see appendix I)
    2. liver function:Total bilirubin ≤ 2 ULN, ALT or AST ≤ 2.5 ULN (or < 5 in case of liver impairment)
    3. neutrophils ≥ 1,ooo/mm3, platelets ≥ 100,000/mm3,Lymphocytes ≥1000
    4. Serum creatinine ≤ 1.5 ULN
  4. Life expectancy of at least 4 months
  5. Pregnancy:

    1. Negative pregnancy test in women of childbearing potential
    2. Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females
  6. prior informed consent signed

Exclusion criteria:

  1. Severe bacterial, viral or fungal infection (Grade > 2 NCI-CTCAE v.4.0)
  2. Any other serious uncontrolled medical condition (including active bleeding or non healing wound)
  3. Pregnant or breastfeeding women
  4. Participation in another clinical trial up to 10 days prior to study entry
  5. Steroid treatment in a dose more than to 3mg dexamethasone / m2 *
  6. Past infection with HCV

Information from the National Library of Medicine

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): NCT01952769

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Hadassah Hebrew University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01952769    
Other Study ID Numbers: antiPD1brainad2- HMO-CTIL
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: October 2015
Keywords provided by Hadassah Medical Organization:
anti PD1,diffuse pontine glioma
Additional relevant MeSH terms:
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Diffuse Intrinsic Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents