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A Randomized Study of Monoclonal Antibody 3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Compared to 13-cis-Retinoic Acid Plus GM-CSF in High Risk Stage 4, Primary Refractory Neuroblastoma Patients


Phase 2
18 Months
13 Years
Not Enrolling
Both
Primary Refractory Neuroblastoma

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Trial Information

A Randomized Study of Monoclonal Antibody 3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Compared to 13-cis-Retinoic Acid Plus GM-CSF in High Risk Stage 4, Primary Refractory Neuroblastoma Patients


Inclusion Criteria:



- Have a diagnosis of stage 4 neuroblastoma diagnosed in accordance with the
International Neuroblastoma Staging System: either (a) histologic confirmation which
may involve immunohistochemical, ultrastructural, and/or cytogenetic studies, or (b)
elevated urinary catecholamines plus tumor cells/clumps in the bone marrow.

- Have evaluable disease or biopsy-proven stable disease in BM by histology or MIBG
scan with MIBG-positive disease confined to the bone or bone marrow, plus urine
catecholamine results, documented >3 weeks after conventional chemotherapy or >6
weeks after stem-cell transplantation. CT, MRI, or bone scan (if necessary) can be
done at 2-3 weeks after conventional chemotherapy confirming that the chemotherapy,
radiotherapy, and ABMT are not realistic curative options.

- Be between 18 months to 13 years old at diagnosis.

- Have recovered to grade 2 or better toxicities since their prior therapy.

- Must, if female of childbearing potential, be willing to use two forms of medically
acceptable contraception (at least one barrier method) and have a negative pregnancy
test at screening and monthly thereafter through the first four cycles of treatment.

- Have a performance score of at least 60 from Lansky Play Performance Scale if aged up
to 16 years or at least 60 from Karnofsky Scale if aged more than 16 years.

- Have voluntarily agreed to participate.

Exclusion Criteria:

- Have measurable disease ≥ 1 cm assessed by CT or MRI.

- Have progressive disease (any new lesion; increase of any measurable lesion by >25%;
or previous negative marrow positive for tumor).

- Have disease detectable in CNS (confirmed by CT or MRI of the brain at screening or
within 8 weeks of randomization).

- Be receiving alternative therapy for the treatment of neuroblastoma, e.g.
radiotherapy or chemotherapy within 3 weeks of randomization.

- Require additional therapy (such as radiotherapy) during the first two treatment
cycles.

- Have detectable human anti-mouse antibody titers at screening.

- Have received prior anti-GD2 investigational therapies.

- Have a history of allergies to mouse proteins.

- Have an active infection requiring IV infusion of antibiotics.

- Be currently receiving long-term chronic treatment with immunosuppressive drugs such
as cyclosporine, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the proportion of patients achieving a complete bone marrow response measured by an absence of histological evidence of bone marrow disease and by MIBG scan after two cycles of treatment.

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Peter E. Zage, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

3F8-NB-201

NCT ID:

NCT00969722

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Primary Refractory Neuroblastoma
  • Neuroblastoma
  • 3F8
  • Primary refractory
  • Neuroblastoma

Name

Location

Vermont Cancer CenterBurlington, Vermont  05401-3498
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Children's Hospitals and Clinics of MinnesotaSaint Paul, Minnesota  55102
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Duke University Medical CenterDurham, North Carolina  27710
The University of Texas M.D. Anderson Cancer CenterHouston, Texas  
US OncologyHouston, Texas  77060
Children's Hospital at MontefioreBronx, New York  10467
University of Utah Medical CenterSalt Lake City, Utah  84132
Nationwide Childrens HospitalColumbus, Ohio  
Rady Children's Hospital of San DiegoSan Diego, California  92123
Georgetown Medical CenterWashington, District of Columbia  20057
All Children's Hospital in FloridaSt. Petersburg, Florida  33701
LSU Health Sciences Center; Children's HospitalNew Orleans, Louisiana  70118
University of Oklahoma Cancer CenterOklahoma City, Oklahoma  73104