Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma

NCT01952769 | Unknown Phase 1

• 1 other identifier: antiPD1brainad2- HMO-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

DIPG

Keywords

anti PD1,diffuse pontine glioma

Outcome Measures

Primary Outcomes (1)

• treatment related toxicity

  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.

  monthly for 1 year or if treatment will be continued further due to response-throughout treatment

Secondary Outcomes (1)

• progression free survival

  6 months

Other Outcomes (1)

• overall survival

  6 months

Study Arms (1)

treatment of DIPG with MDV9300

EXPERIMENTAL

treatment of diffuse pontine glioma with MDV9300 with the combination of radiation and low dose cyclophosphamide

Biological: MDV9300

Interventions

MDV9300 BIOLOGICAL

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

Also known as: pidilizumab

treatment of DIPG with MDV9300

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 3-21
• 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
• patient status:
• karnofsky or lansky (for children) scale of 60 or more (see appendix I)
• liver function:Total bilirubin ≤ 2 ULN, ALT or AST ≤ 2.5 ULN (or \< 5 in case of liver impairment)
• neutrophils ≥ 1,ooo/mm3, platelets ≥ 100,000/mm3,Lymphocytes ≥1000
• Serum creatinine ≤ 1.5 ULN
• Life expectancy of at least 4 months
• Pregnancy:
• Negative pregnancy test in women of childbearing potential
• Use of an effective contraceptive method during the whole treatment and up to 3 months after the completion of treatment in males and females
• prior informed consent signed

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

pidilizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2013
• First Posted: September 30, 2013
• Study Start: February 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 13, 2016

Record last verified: 2015-10

Locations

IL (1)