Phase 1 Study on the Use of Racotumomab Anti-idiotype Antibody in Patients With Pediatric Malignancies That Express N-glycolylated Gangliosides and Are Resistant to Conventional Treatment.
1 Year
10 Years
Both
Neuroblastoma, Ewing's Sarcoma, Wilm's Tumor, Retinoblastoma, Glioma
Trial Information
Phase 1 Study on the Use of Racotumomab Anti-idiotype Antibody in Patients With Pediatric Malignancies That Express N-glycolylated Gangliosides and Are Resistant to Conventional Treatment.
Inclusion Criteria:
- Children (both genders) of between 1 and 10 years old at the time of accrual.
- Diagnosis of neuroblastoma (progression after first line treatment), glioma
(progressing disease or metastatic disease, without curative treatment options),
Ewing's sarcoma (progressive metastatic disease to first line treatment or
progressive disease to second line treatment), Wilm's tumor (metastatic relapse after
treatment), or retinoblastoma (progressing disease or metastatic relapse during or
after first line treatment).
- Previous cancer treatment finished 30 days before accrual.
- Lansky performance status over 50.
Exclusion Criteria:
- History of encephalopathy, convulsions, asthma or severe allergy.
- Infectious disease grade 3 or 4 according to CTCAE version 3.
- Hepatic, kidney or cardiac insufficiency.
- Marrow insufficiency after self-transplantation of hematopoietic stem cells.
- Weight inferior to 12 kg at the time of accrual.
- Concomitant cancer treatment.
- Inability to comply with study procedures.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Selection of the higher safe dose level for ensuing clinical trials
Outcome Description:
One of the three dose levels assessed in this study will be selected for further clinical testing in children: 0.15 mg, 0,25 mg or 0.4 mg.
Outcome Time Frame:
Up to 1 year
Safety Issue:
Yes
Principal Investigator
Walter Cacciavillano, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Prof. Dr. J. P. Garrahan National Children's Hospital
Authority:
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study ID:
AR-RACO-1-2-09
NCT ID:
NCT01598454
Start Date:
February 2011
Completion Date:
September 2013
Related Keywords:
- Neuroblastoma
- Ewing's Sarcoma
- Wilm's Tumor
- Retinoblastoma
- Glioma
- Glioma
- Wilms Tumor
- Neuroblastoma
- Retinoblastoma
- Sarcoma, Ewing's
- Neuroectodermal Tumors, Primitive, Peripheral
- Sarcoma
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