Using Iodine I 131 Metaiodobenzylguanidine to treat advanced neuroblastoma and pheochromocytoma
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
This study is testing if a special treatment called Iodine I 131 Metaiodobenzylguanidine can help people with hard-to-treat neuroblastoma and pheochromocytoma feel better when other treatments haven’t worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT00107289 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of Iodine I 131 Metaiodobenzylguanidine (131 I-MIBG) in patients suffering from recurrent, progressive, or refractory neuroblastoma and malignant pheochromocytoma or paraganglioma. The study aims to determine how well this treatment works in patients whose tumors have not responded to standard therapies. Participants must have tumors that are MIBG-avid and evaluable on scans, and they must meet specific eligibility criteria regarding prior treatments and age. The trial is being conducted at the Memorial Sloan Kettering Cancer Center, a leading institution in cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include patients over one year old with recurrent or refractory neuroblastoma or malignant pheochromocytoma who have MIBG-avid tumors.
Not a fit: Patients with tumors that are not MIBG-avid or those who have not met the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat neuroblastoma and pheochromocytoma.
How similar studies have performed: Other studies have shown promising results with similar approaches using I-131 MIBG for treating neuroblastoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Determination that radiation safety restrictions during therapy period can be implemented. * Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. 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.
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ellen Basu, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Ellen Basu, MD, PhD
- Phone: 212-639-5204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.