Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 21 |
| Updated: | 6/22/2018 |
| Start Date: | December 2011 |
| End Date: | December 2018 |
| Contact: | Mark Souweidane, MD |
| Phone: | 212-639-2336 |
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
The purpose of this study is to test the safety of a new method to treat Diffuse Intrinsic
Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to
deliver an agent called 124I-8H9. CED is performed during surgery. The study agent is infused
through a small tube placed into the tumor in the brain. Many studies have shown this can
safely be done in animals but this study is the first time 124I-8H9 will be given by CED in
humans. This will be one of the first times that CED has been performed in the brain stem.
8H9 is something called an antibody. Antibodies are made by the body to fight infections and
sometimes cancer. The antibody 8H9 is produced by mice and can attack many kinds of tumors. A
radioactive substance, 124I, is attached to 8H9. 124I-8H9 sticks to parts of tumor cells and
can cause the tumor cells to die from radiation. Studies have also been done on humans using
124I-8H9 to treat other kinds of cancer. Our studies of some DPG and related tumors suggest
that 8H9 will bind to the tumor, but the investigators don't know that for sure.
In this study, the researchers want to find out how safe 124I-8H9 given by CED is at
different dose levels. They will look to see what effects (both good and bad) it has on the
patient. The dose of 124I-8H9 will increase for each new group of patients. The procedure has
already been safely performed with lower doses and infusion volumes in a number of patients
here at MSKCC. The amount they get will depend on when they enter the study. If too many
serious side effects are seen with a certain dose, no one will be treated with a higher dose,
and some more patients may be treated with a lower dose to make sure that dose is safe.
Pontine Glioma (DIPG). The researchers will use "convection-enhanced delivery" (CED) to
deliver an agent called 124I-8H9. CED is performed during surgery. The study agent is infused
through a small tube placed into the tumor in the brain. Many studies have shown this can
safely be done in animals but this study is the first time 124I-8H9 will be given by CED in
humans. This will be one of the first times that CED has been performed in the brain stem.
8H9 is something called an antibody. Antibodies are made by the body to fight infections and
sometimes cancer. The antibody 8H9 is produced by mice and can attack many kinds of tumors. A
radioactive substance, 124I, is attached to 8H9. 124I-8H9 sticks to parts of tumor cells and
can cause the tumor cells to die from radiation. Studies have also been done on humans using
124I-8H9 to treat other kinds of cancer. Our studies of some DPG and related tumors suggest
that 8H9 will bind to the tumor, but the investigators don't know that for sure.
In this study, the researchers want to find out how safe 124I-8H9 given by CED is at
different dose levels. They will look to see what effects (both good and bad) it has on the
patient. The dose of 124I-8H9 will increase for each new group of patients. The procedure has
already been safely performed with lower doses and infusion volumes in a number of patients
here at MSKCC. The amount they get will depend on when they enter the study. If too many
serious side effects are seen with a certain dose, no one will be treated with a higher dose,
and some more patients may be treated with a lower dose to make sure that dose is safe.
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 ≥ 50 at study entry .
Lansky Performance scale will be used for patients ≤16 years of age.
- The patient must be ≥ 2 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.
We found this trial at
2
sites
445 E 69th St
New York, New York 10021
New York, New York 10021
(212) 746-1067
Phone: 212-639-2336
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Mark Souweidane, MD
Phone: 212-639-2336
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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