Clinical trial · Interventional
Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma
A Phase I/ II Clinical Trial of MDV9300 (Pidilizumab) in Diffuse Intrinsic Pontine Glioma
NCT01952769CI-TRIAL-00023856unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DIPG | Diffuse Intrinsic Pontine Glioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDV9300 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment of DIPG with MDV9300
- description
- treatment of diffuse pontine glioma with MDV9300 with the combination of radiation and low dose cyclophosphamide
- interventionNames
- Biological: MDV9300
Primary outcomes (1)
- measure
- treatment related toxicity
- timeFrame
- monthly for 1 year or if treatment will be continued further due to response-throughout treatment
- description
- 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 outcomes (1)
- measure
- progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.