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 |
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.
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
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...
Click here to add this to my saved trials