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Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors


Phase 2
1 Year
N/A
Open (Enrolling)
Both
Neuroblastoma, Pheochromocytoma

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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 CenterNew York, New York  10021