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International Phase II Studies of I-mIBG in Combination With Topotecan and Peripheral Blood Stem Cell Rescue for (A) Primary Resistant High Risk Neuroblastoma and (B) Relapsed Stage 4 Neuroblastoma


Phase 2
1 Year
17 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

International Phase II Studies of I-mIBG in Combination With Topotecan and Peripheral Blood Stem Cell Rescue for (A) Primary Resistant High Risk Neuroblastoma and (B) Relapsed Stage 4 Neuroblastoma


OBJECTIVES:

- Determine response (partial and complete response at metastatic sites) in children with
relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma treated
with high-dose iodine I 131 metaiodobenzylguanidine, topotecan hydrochloride, and
peripheral blood stem cell transplantation.

- Determine the proportion of patients who, as a result of this treatment, are able to
progress to potentially curative surgery and further systemic treatment.

- Correlate tumor dosimetry (to determine whether the tumor absorbed the radiation dose)
with response in patients treated with this regimen.

- Determine the time to tumor progression.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
disease type (relapsed stage 4 vs primary resistant high-risk neuroblastoma).

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 15-19 and
high-dose iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes on days 1 and
15. Patients receive autologous CD 34+ peripheral blood stem cells when ^131I-MIBG dosimetry
levels reach an acceptable low on days 25-29.

Total whole-body absorbed dose is measured periodically after the first ^131I-MIBG dose is
administered and periodically thereafter.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 67 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:

- Primary resistant high-risk disease meeting the following criteria:

- International neuroblastoma staging system (INSS) stage 4, or stage 2 or 3
with myelocytomatosis viral-related oncogene (MycN) amplification

- Failed to achieve satisfactory remission with induction chemotherapy,
defined as one of the following:

- Less than 50% reduction or > 3 positive sites on iodine I 131
metaiodobenzylguanidine (^131I-MIBG) scintigraphy

- Persistent cytomorphological positive disease in bone marrow aspirates
or trephine biopsies

- Progressive disease necessitating a change of treatment

- Relapsed stage 4 disease meeting the following criteria:

- High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN
amplification)

- Relapsed after intensive treatment including high-dose chemotherapy and
hematopoietic progenitor cell support

- Patients may be entered at the time of relapse, or at any point
subsequently after other treatments

- ^131I-MIBG-positive disease on diagnostic scintigraphy

- Peripheral blood stem cell harvest ≥ 300,000/mm³ CD 34+ cells

- Enrolled in or has been treated on protocol SIOP-NB-2009 or a similar protocol

PATIENT CHARACTERISTICS:

- Glomerular filtration rate ≥ 50 mL/min

- Considered fit enough to undergo proposed study treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who respond to treatment (partial response and complete response at metastatic sites) as measured by metaiodobenzylguanidine scintigraphy and positron emission tomography and CT imaging

Safety Issue:

No

Principal Investigator

Mark N. Gaze, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals

Authority:

Unspecified

Study ID:

CDR0000508611

NCT ID:

NCT00389766

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Neuroblastoma
  • localized unresectable neuroblastoma
  • recurrent neuroblastoma
  • regional neuroblastoma
  • localized resectable neuroblastoma
  • disseminated neuroblastoma
  • Neuroblastoma

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