Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028106
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-12-11
Brief Title:
131MIBG to Treat Malignant Pheochromocytoma
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
131I-Metaiodobenzylguanidine Treatment of Malignant Pheochromocytoma
Status:
COMPLETED
Status Verified Date:
2008-08-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of 131MIBG in treating malignant pheochromocytoma and whether sensitization medications improve the response to treatment Pheochromocytoma is a rare type of tumor that usually occurs in the adrenal glands The tumor cells release chemicals like adrenaline that can cause large increases in blood pressure and pulse rate with serious health consequences Tumor in the adrenal glands usually can be removed surgically but if the pheochromocytoma is malignant-ie has spread to many sites in the body-or is located in places where surgery is difficult or impossible no satisfactory treatment is available 131MIBG is a combination of an adrenaline-like chemical and a radioactive form of iodine The 131MIBG attaches to the tumor cells and the high concentration of radioactive iodine kills them Previous studies using 131MIBG to treat pheochromocytoma had a 36 response rate in terms of complete or partial improvement This study will examine whether adding other sensitization medications to the 131MIBG treatment regimen will enhance its effectiveness in reducing the size and number of tumors
Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be eligible for this 18-month study Candidates will be screened with various tests and procedures which may include a medical history physical examination blood and urine tests lung function studies electrocardiogram echocardiogram computed tomography CT magnetic resonance imaging MRI positron emission tomography PET and bone scans and other scans using radioactive MIBG and octreotide
Participants will be randomly assigned to one of two treatment groups 1 131MIBG plus sensitization medications or 2 131MIBG alone All patients will be hospitalized 3 to 5 days for each 131MIBG treatment The drug will be infused through a vein intravenously or IV over 10 to 30 minutes Patients will receive up to 3 treatments separated by at least 3 months All patients will also take potassium to protect the thyroid gland from radioactive iodine generated by the 131MIBG The potassium is taken twice a day for 30 days beginning the day before the 131MIBG treatment Patients in the sensitization group will receive the following additional drugs for sensitization methylprednisolone intravenously a few minutes before 131MIBG treatment Roaccutan by mouth capsules twice a day for 6 weeks before treatment Demser by mouth 3 times a week for 1 week before treatment and Carbidopa by mouth every 6 hours for 4 days before treatment
After each treatment patients will have a clinical evaluation and periodic blood tests to check for adverse side effects of radiotherapy Follow-up visits at NIH will be scheduled at 12 and 18 months after the first 131MIBG treatment for clinical laboratory and imaging tests Patients who had tumors in the lungs before treatment will have lung function tests 1 3 and 6 months after each treatment CT MRI 131MIBG and PET scanning will be done 1 week before each treatment
Patients who have tumors that have grown by more than 25 and none that have shrunk by more than 50 or who have developed one or more new tumors while on 131MIBG treatment will be taken off the study
Patients 18 years of age and older with malignant or inoperable pheochromocytoma may be eligible for this 18-month study Candidates will be screened with various tests and procedures which may include a medical history physical examination blood and urine tests lung function studies electrocardiogram echocardiogram computed tomography CT magnetic resonance imaging MRI positron emission tomography PET and bone scans and other scans using radioactive MIBG and octreotide
Participants will be randomly assigned to one of two treatment groups 1 131MIBG plus sensitization medications or 2 131MIBG alone All patients will be hospitalized 3 to 5 days for each 131MIBG treatment The drug will be infused through a vein intravenously or IV over 10 to 30 minutes Patients will receive up to 3 treatments separated by at least 3 months All patients will also take potassium to protect the thyroid gland from radioactive iodine generated by the 131MIBG The potassium is taken twice a day for 30 days beginning the day before the 131MIBG treatment Patients in the sensitization group will receive the following additional drugs for sensitization methylprednisolone intravenously a few minutes before 131MIBG treatment Roaccutan by mouth capsules twice a day for 6 weeks before treatment Demser by mouth 3 times a week for 1 week before treatment and Carbidopa by mouth every 6 hours for 4 days before treatment
After each treatment patients will have a clinical evaluation and periodic blood tests to check for adverse side effects of radiotherapy Follow-up visits at NIH will be scheduled at 12 and 18 months after the first 131MIBG treatment for clinical laboratory and imaging tests Patients who had tumors in the lungs before treatment will have lung function tests 1 3 and 6 months after each treatment CT MRI 131MIBG and PET scanning will be done 1 week before each treatment
Patients who have tumors that have grown by more than 25 and none that have shrunk by more than 50 or who have developed one or more new tumors while on 131MIBG treatment will be taken off the study
Detailed Description:
Pheochromocytomas are tumors of chromaffin cells that synthesize catecholamines This project tests the efficacy of radiotoxic treatment of malignant pheochromocytoma using 131I-metaiodobenzylguanidine 131I-MIBG and in particular tests whether pre-treatment with enhancer pharmaceuticals increases the efficacy of experimental 131I-MIBG treatment in reducing the size and number of tumors and the tumor burden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-0032 | None | None | None |