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A Phase I Study of Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy


Phase 1
3 Years
21 Years
Open (Enrolling)
Both
Brain Cancer, Brain Stem Glioma

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Trial Information

A Phase I Study of Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy


Inclusion Criteria:



- Consensus of diagnosis must be reached by a multidisciplinary pediatric
neuro-oncology team by considering both clinical evidence and MRI presentation.
Tissue diagnosis is not required.

- The patient must have undergone prior external beam radiotherapy to a dose of 54-60
Gy to the brain stem. At least 4 weeks but no more than 14 weeks must have elapsed
from the completion of radiotherapy.

- The patient must be in adequate general condition for study, with Lansky or Karnofsky
Performance Score of > or = to 50 at study entry .

Lansky Performance scale will be used for patients ≤16 years of age.

- The patient must be > to or = to 3 and ≤ 21 years old.

- Patient must weigh a minimum of 8 kg.

Exclusion Criteria:

- Clinical and/or radiographic (MRI) progression of tumor following external beam
radiation therapy.

- Metastatic disease.

- Untreated symptomatic hydrocephalus determined by treating physician.

- AST or ALT > 2x the upper limit of normal.

- Platelets < 100,000/mcL.

- ANC < 1000/mcL.

- Abnormal PT (Inr) >1.5 INR or PTT > 42 sec (may be corrected with FFP,
cryoprecipitate, vitamin K, etc).

- Total bilirubin > 2.0 mg/dl.

- Serum creatinine > 1.5x the upper limit of normal for age, or calculated creatinine
clearance or nuclear GFR < 70 ml/min/1.73 m2.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Description:

Determination that a dose is safe will be made following the treatment of at least 3 but no more than 6 patients at a particular dose level. The dose levels are DL1 (0.25 mCi), DL2 (0.5 mCi), DL3 (0.75 mCi), DL4 (1 mCi) and fallback DL0 (0.125 mCi). An incidence of dose-limiting toxicity (DLT) in the range of 25% is considered acceptable in this population.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mark Souweidane, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

11-011

NCT ID:

NCT01502917

Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Brain Cancer
  • Brain Stem Glioma
  • Brain stem glioma
  • CNS
  • MAB 124I-8H9
  • infusion cannula
  • DIPG
  • Diffuse Intrinsic Pontine Glioma
  • 11-011
  • Brain Neoplasms
  • Glioma
  • Pontine Glioma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Weill Medical College of Cornell UniversityNew York, New York  10021