Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
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Purpose
RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Giving iodine I 131 metaiodobenzylguanidine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine works in treating patients with recurrent, progressive, or refractory neuroblastoma or malignant pheochromocytoma or paraganglioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma Pheochromocytoma |
Radiation: iobenguane I 131 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors |
- Response (complete or partial) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Correlation between tumor self-absorbed dose and response and tumor volume decrease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Radiation |
Radiation: iobenguane I 131
Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 1-4 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation. After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year. |
Detailed Description:
OBJECTIVES:
Primary
- Utilize targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG) in treating patients with recurrent, progressive, or refractory neuroblastoma (NB) or malignant chromaffin cell tumors (CCT).
- Determine the response rate in patients with NB treated with this regimen.
- Determine, preliminarily, the toxicity and efficacy of this regimen in patients with malignant CCT.
Secondary
- Determine the whole-body dosimetry of ^131I-MIBG in these patients.
- Determine the tumor dosimetry of ^131I-MIBG in patients with measurable soft tissue disease.
OUTLINE: This is an open-label, pilot study.
Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 1-4 hours on day 0. Patients undergo radiation dosimetry following the first dose of ^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) 6-8 weeks after the first dose if response is achieved and patients do not experience major toxicity.
After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation.
After completion of study treatment, patients are followed at 4-6 weeks after ^131I-MIBG administration and then every 3 months for up to 1 year.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Neuroblastoma (NB)
Meets 1 of the following criteria:
- Histologically confirmed disease
- Bone marrow involvement with elevated urinary catecholamines
- Progressive or recurrent disease OR failed to achieve a complete response to prior standard therapy
- Malignant chromaffin cell tumors (CCT) (i.e., malignant pheochromocytoma or malignant paraganglioma)
Evaluable disease on metaiodobenzylguanidine (MIBG) scan
- MIBG-avid disease
- Must have ≥ 2 x 10^6 CD 34+ autologous peripheral blood stem cells cryopreserved and available for reinfusion after study therapy
- Ineligible for other Memorial Sloan-Kettering Cancer Center protocols that use monoclonal antibody 3F8 (patients with NB only)
PATIENT CHARACTERISTICS:
Age
- Over 1 (patients with NB)
- 1 to 21 (patients with CCT)
Performance status
- Not specified
Life expectancy
- At least 8 weeks
Hematopoietic
- See Disease Characteristics
Hepatic
- No hepatic toxicity > grade 2
Renal
- Creatinine clearance > 60 mL/min
- No renal toxicity > grade 2
Cardiovascular
- No cardiac toxicity > grade 2
Pulmonary
- No pulmonary toxicity > grade 2
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No gastrointestinal toxicity > grade 2
- No neurologic toxicity > grade 2
- No hearing deficit > grade 3
- No other severe major organ toxicity
- No active, serious infection not controlled by antibiotics
- Able and willing to comply with radiation safety procedures
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 2 weeks since prior biologic therapy
Chemotherapy
- At least 3 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Shakeel Modak, MD 212-639-7623 | |
| Contact: Nai-Kong Cheung, MD 646-888-2313 | |
| Principal Investigator: Shakeel Modak, MD | |
| Study Chair: | Shakeel Modak, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00107289 History of Changes |
| Other Study ID Numbers: | 04-148, MSKCC-04148 |
| Study First Received: | April 5, 2005 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
metastatic pheochromocytoma recurrent pheochromocytoma regional pheochromocytoma recurrent neuroblastoma 04-148 |
Additional relevant MeSH terms:
|
Neuroblastoma Pheochromocytoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Paraganglioma Neuroendocrine Tumors 3-Iodobenzylguanidine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013