Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00450827
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • filgrastim — BIOLOGICAL
  • autologous hematopoietic stem cell transplantation — PROCEDURE
  • iodine I 131 monoclonal antibody 3F8 — RADIATION

Study Details

RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma.

Key Dates

First listed
Mar 22, 2007
Start date
Aug 31, 2006
Status verified
Sep 2015
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab
    Patients will be administered a therapeutic doses of intravenous (IV) 131I-3F8 given in a single dose per the dose escalation regimen on day 0 of study. This will be followed by blood draws for pharmacokinetic and dosimetry studies and by gamma camera scan, where feasible. Bevacizumab will be administered at a fixed dose of 15mg/kg on days 1 and 15. Thyroid protection is commenced 10 days prior to administration of 131I-3F8 and continued for 28 days after the therapeutic dose of 131I-3F8. ASCR will be carried out if ANC \< 500/ul on day 28 (blood radioactivity will be confirmed to be \<1 uCi/ml prior to ASCR). ASCR will be carried out sooner in the case of life-threatening infection in the setting of neutropenia (ANC\<500). G-CSF can be used to maintain ANC\>500/ul but should not be used for 24 hours immediately before and after ASCR. Blood product support will be provided with platelet and red cell transfusions as required.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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