Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00107289
First received: April 5, 2005
Last updated: April 23, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Response (complete or partial) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2015
Estimated Primary Completion Date: May 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107289

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         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
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: April 23, 2014
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 July 24, 2014