Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides
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 other identifier
interventional
15
1 country
1
Brief Summary
This study will be carried out in children with diagnosis of cancer with tumors known to express N-glycolylated gangliosides. The disease must be resistant to conventional therapy. The acute toxicity and immune response will be evaluated. The expression of N-glycolylated gangliosides in tumors has previously been investigated in the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma. Gliomas and the aforementioned tumor types have a very bad prognosis when conventional treatment is ineffective. New therapeutic strategies have thus been examined, and several immunotherapeutic approaches, including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently being assessed. Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies in patients with melanoma, breast cancer and lung cancer. Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range. The 1 mg dose level was selected for the ensuing clinical studies. This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg, owing to the difference in body surface between an adult (1.73 sq. m in average) and the candidate population for this study (0.55 to 0.7 sq. m).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 29, 2015
July 1, 2015
3.1 years
May 10, 2012
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Selection of the higher safe dose level for ensuing clinical trials
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.
Up to 1 year
Secondary Outcomes (1)
Assess the immune response to racotumomab treatment
Up to 1 year
Study Arms (1)
Racotumomab
EXPERIMENTALInterventions
Dosage form: intradermal injection. Dosage: 0.15 mg; 0.25 mg; 0.4 mg. Frequency: 3 biweekly injections or 6 biweekly injections. Duration: 4 weeks or 10 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof. Dr. J. P. Garrahan National Children's Hospital
Buenos Aires, 1245, Argentina
Related Publications (1)
Cacciavillano W, Sampor C, Venier C, Gabri MR, de Davila MT, Galluzzo ML, Guthmann MD, Fainboim L, Alonso DF, Chantada GL. A Phase I Study of the Anti-Idiotype Vaccine Racotumomab in Neuroblastoma and Other Pediatric Refractory Malignancies. Pediatr Blood Cancer. 2015 Dec;62(12):2120-4. doi: 10.1002/pbc.25631. Epub 2015 Jul 7.
PMID: 26154941RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Cacciavillano, MD
Prof. Dr. J. P. Garrahan National Children's Hospital
- STUDY DIRECTOR
Guillermo Chantada, MD
Prof. Dr. J. P. Garrahan National Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 15, 2012
Study Start
February 1, 2011
Primary Completion
March 1, 2014
Study Completion
June 1, 2015
Last Updated
July 29, 2015
Record last verified: 2015-07