Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
1 Year
N/A
Both
Neuroblastoma, Pheochromocytoma
Trial Information
Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response (complete or partial)
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Shakeel Modak, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
04-148
NCT ID:
NCT00107289
Start Date:
May 2006
Completion Date:
May 2014
Related Keywords:
- Neuroblastoma
- Pheochromocytoma
- metastatic pheochromocytoma
- recurrent pheochromocytoma
- regional pheochromocytoma
- recurrent neuroblastoma
- 04-148
- Neuroblastoma
- Pheochromocytoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
