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Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01598454
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Laboratorio Elea Phoenix S.A.

Study Description
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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).


Condition or disease Intervention/treatment Phase
Neuroblastoma Ewing's Sarcoma Wilm's Tumor Retinoblastoma Glioma Drug: racotumomab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Racotumomab Drug: racotumomab
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.


Outcome Measures
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Primary Outcome Measures :
  1. Selection of the higher safe dose level for ensuing clinical trials [ Time Frame: Up to 1 year ]
    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.


Secondary Outcome Measures :
  1. Assess the immune response to racotumomab treatment [ Time Frame: Up to 1 year ]
    Active specific immunotherapy with racotumomab has shown to elicit antigen-specific immune responses in adult patients. The elicitation of anti-immunogen and anti-ganglioside antibodies will be assessed in serum samples prior and after racotumomab treatment.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598454


Locations
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Argentina
Prof. Dr. J. P. Garrahan National Children's Hospital
Buenos Aires, Argentina, 1245
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
Ministerio de Ciencia e Innovación, Spain
Investigators
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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
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Laboratorio Elea Phoenix S.A.
ClinicalTrials.gov Identifier: NCT01598454    
Other Study ID Numbers: AR-RACO-1-2-09
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Neuroblastoma
Sarcoma, Ewing
Wilms Tumor
Retinoblastoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases