Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma



Status:Recruiting
Conditions:Brain Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - Any
Updated:2/8/2019
Start Date:May 2006
End Date:May 2019
Contact:Ellen Basu, MD, PhD
Phone:212-639-5204

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Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

The purpose of this research study is to find how active and safe 131 I-MIBG is in patients
with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.


Inclusion criteria for NB:

- Patients must have the diagnosis of NB in accordance with the International Criteria,
i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM
involvement plus elevated urinary catecholamines.

- Must have a history of tumor progression or recurrence or failure to achieve complete
response with standard therapy.

- Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of
enrollment on protocol

- Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three
weeks should have elapsed since last dose of chemotherapy.

- Age >1 year with a determination that radiation safety restrictions during therapy
period can be implemented.

- Stem cells: Patients must have an autologous hematopoietic stem cell product
cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for
peripheral blood stem cells is 2 X106 CD34+ cells/kg.

- Minimum life expectancy of eight weeks

- Signed informed consent indicating awareness of the investigational nature of this
program.

Inclusion criteria for malignant CCT:

- Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or
malignant paraganglioma

- Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time
of enrollment on protocol

- Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three
weeks should have elapsed since last dose of chemotherapy.

- Age between 1 and 21 years and able to cooperate with radiation safety restrictions
during therapy period

- Stem cells: Patients must have an autologous hematopoietic stem cell product
cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for
peripheral blood stem cells is 2 X106 CD34+ cells/kg.

- Minimum life expectancy of eight weeks.

- Signed informed consent indicating awareness of the investigational nature of this
program.

Exclusion Criteria:

- Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary,
gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3
hearing deficit is acceptable.

- Active serious infections not controlled by antibiotics.

- Pregnant women are excluded for fear of danger to the fetus. Therefore negative
pregnancy test is required for all women of child-bearing age, and appropriate
contraception is used during the study period.

- Inability or unwillingness to comply with radiation safety procedures or protocol
requirements.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Ellen Basu, MD, PhD
Phone: 212-639-5204
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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