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A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma Or Melanoma
This study is currently recruiting participants.
Verified January 2012 by St. Jude Children's Research Hospital

First Received on August 27, 2008.   Last Updated on January 9, 2012   History of Changes
Sponsor: St. Jude Children's Research Hospital
Information provided by (Responsible Party): St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00743496
  Purpose

Relapsed and/or refractory neuroblastoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigational) antibody called hu14.18K322A. Some responses have been seen in these 2 tumor types to similar antibodies.

Hu14.18K322A antibody will be administered intravenously at a starting dose of 2 mg/m2 daily for 4 consecutive days. The dosage will be repeated every 28 days. Approximately 25-30 participants will be required to define the maximum tolerated dose. Participants will continue on treatment for a maximum of 4 courses or until one or more of the criteria for off-treatment are met.


Condition Intervention Phase
Neuroblastoma
Melanoma
Biological: Anti-G2 antibody
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma Or Melanoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma or melanoma. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: August 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Anti-G2 antibody
Anti-G2 antibody

Detailed Description:

SJGD2 is Phase I dose finding study. The primary purpose of this phase I study is to determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma or melanoma.

Initially, one research participant will be treated at the lowest dose level and if no toxicity is observed then the next participant will be treated at the next dose level. This is continued until the first instance of biological activity (in the form of grade 2 side effects) is observed and from that point on a traditional phase I study design will be followed.

Secondary objectives include:

  1. Estimate the response rate, within the confines of a phase I study, to the humanized anti-GD2 antibody, hu14.18K322A.
  2. Evaluate the pharmacokinetics of hu14.18K322A.
  3. Examine whether or not human anti-human antibodies (HAHA) develop in participants receiving hu14.18K322A.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis: Recurrent or refractory neuroblastoma or melanoma.
  • Age: < 21 years of age at the time of enrollment.
  • Does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2).
  • Life expectancy: at least 8 weeks.
  • Organ Function: Must have adequate organ and marrow function
  • Performance status: Karnofsky > 50 for > 10 years of age; Lansky > 50 for children < 10 years of age (see Appendix III).
  • Prior Therapy: Patient must have fully recovered from the acute toxic effects of all prior therapy prior to enrolling on study.
  • Myelosuppressive Chemotherapy: Must not have received myelosuppressive therapy within 2 weeks prior to study entry (4 weeks if nitrosurea).
  • Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with biologic agent, including retinoic acid. Participants receiving IVIG are eligible; however, participant must not receive IVIG during the 4 days of antibody infusion.
  • Radiation therapy: At least 2 weeks since prior local radiation therapy at the time of study entry.
  • Growth factors: Must not have received hematopoietic growth factors (G-CSF, GM-CSF) for at least 1 week prior to study entry.
  • Investigational agent: Must not have received investigational agent within 14 days of study entry.
  • Immune therapy: Must not have received immunosuppressive (including glucocorticoids), immunostimulatory or any immunomodulatory treatment within 2 weeks of study entry
  • Patients may have had prior CNS metastasis providing: CNS disease has been previously treated and CNS disease has been clinically stable for 4 weeks prior to study entry (assessment must be made by CT or MRI).
  • Written informed consent following institutional and federal guidelines.

Exclusion Criteria:

  • Prior monoclonal antibody: Participants having received in vivo monoclonal antibodies for biologic therapy or for tumor imaging are ineligible unless serologic testing is performed which documents the absence of detectable antibody (over background) to hu14.18.
  • Pregnancy or Breast Feeding: Study participants who are pregnant are not eligible for this study. Pregnancy tests must be obtained in girls who are > 10 years of age or post-menarchal within 7 days prior to study enrollment. - - Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during participation in the trial. Breast feeding should be discontinued if a mother wishes to participate in this study.
  • Allergy: known hypersensitivity to other recombinant human antibodies.
  • An uncontrolled infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743496

Contacts
Contact: Fariba Navid, MD info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Fariba Navid, MD         info@stjude.org    
Principal Investigator: Fariba Navid, MD            
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Fariba Navid, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00743496     History of Changes
Other Study ID Numbers: SJGD2
Study First Received: August 27, 2008
Last Updated: January 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroblastoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012