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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier:
NCT01598454
First received: May 10, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Neuroblastoma
Ewing's Sarcoma
Wilm's Tumor
Retinoblastoma
Glioma
Drug: racotumomab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Laboratorio Elea S.A.C.I.F. y A.:

Primary Outcome Measures:
  • Selection of the higher safe dose level for ensuing clinical trials [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Assess the immune response to racotumomab treatment [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01598454

Locations
Argentina
Prof. Dr. J. P. Garrahan National Children's Hospital
Buenos Aires, Argentina, 1245
Sponsors and Collaborators
Laboratorio Elea S.A.C.I.F. y A.
Ministerio de Ciencia e Innovación, Spain
Investigators
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

Additional Information:
No publications provided

Responsible Party: Laboratorio Elea S.A.C.I.F. y A.
ClinicalTrials.gov Identifier: NCT01598454     History of Changes
Other Study ID Numbers: AR-RACO-1-2-09
Study First Received: May 10, 2012
Last Updated: July 15, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Neuroblastoma
Sarcoma, Ewing
Retinoblastoma
Wilms Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Neoplasms, Complex and Mixed
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014