Iodine I 131 Metaiodobenzylguanidine and Arsenic Trioxide in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00107289

Purpose

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide may also make the tumor cells more sensitive to iodine I 131 metaiodobenzylguanidine. Giving iodine I 131 metaiodobenzylguanidine together with arsenic trioxide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with arsenic trioxide works in treating patients with recurrent, progressive, or refractory neuroblastoma or malignant pheochromocytoma or paraganglioma.

Condition	Intervention	Phase
Neuroblastoma Pheochromocytoma	Drug: arsenic trioxide Drug: iodine I 131 metaiodobenzylguanidine	Phase II

MedlinePlus related topics: Arsenic Cancer Neuroblastoma Pheochromocytoma

Drug Information available for: Iodine Cadexomer iodine Sodium iodide I 131 Arsenic trioxide 3-Iodobenzylguanidine Iobenguane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Pilot Phase II Study of Targeted Radiotherapy With I-Metaiodobenzylguanidine (I-MIBG) in Combination With Arsenic Trioxide in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response (complete or partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between tumor self-absorbed dose and response and tumor volume decrease [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	May 2006
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the feasibility of targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG) combined with arsenic trioxide in patients with recurrent, progressive, or refractory neuroblastoma (NB) or malignant chromaffin cell tumors (CCT).
Determine the toxicity of this regimen in patients with NB.
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 2 hours on day 0. Patients also receive arsenic trioxide IV over 1-4 hours daily on days 5-9 and 12-16 in the absence of disease progression or unacceptable 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.

PROJECTED ACCRUAL: A total of 23-38 patients (13-28 with recurrent, progressive, or refractory neuroblastoma, 10 with malignant chromaffin cell tumors) will be accrued for this study within 3 years.

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

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, 10021
Contact: Shakeel Modak, MD 212-639-7623 modaks@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Study Chair:

Shakeel Modak, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Shakeel Modak )
Study ID Numbers:	CDR0000422319, MSKCC-04148
Study First Received:	April 5, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00107289
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

metastatic pheochromocytoma
recurrent pheochromocytoma
regional pheochromocytoma
recurrent neuroblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors, Primitive
Arsenic trioxide
Neuroblastoma
Pheochromocytoma
Recurrence
Neuroendocrine Tumors
Neuroectodermal Tumors

Paraganglioma
3-Iodobenzylguanidine
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Iodine
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Enzyme Inhibitors

Trace Elements
Pharmacologic Actions
Anti-Infective Agents, Local
Neoplasms
Therapeutic Uses
Micronutrients
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009