Skip to main content
OpenTrials
Completed

NCT Number: NCT01598454

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuroblastoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ewing's Sarcoma Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Glioma Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Osteosarcoma Retinal Diseases Retinal Neoplasms Retinoblastoma Sarcoma Sarcoma, Ewing Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilm's Tumor Wilms Tumor

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prof. Dr. J. P. Garrahan National Children's Hospital

Buenos Aires, 1245, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

racotumomab

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Laboratorio Elea Phoenix S.A.

Industry

Collaborators

  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
May 15, 2012
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.