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A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma Or Melanoma

Phase 1
21 Years
Open (Enrolling)
Neuroblastoma, Melanoma, Osteosarcoma

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Trial Information

A Phase I Trial Of The Humanized Anti-GD2 Antibody (HU14.18K322A) In Children And Adolescents With Neuroblastoma, Osteosarcoma Or Melanoma

SJGD2 is Phase I dose finding study. The primary purpose of this phase I study is to
determine maximum tolerated dose (MTD) and dose-limiting toxicity of two schedules (daily x
4 or weekly x 4) 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

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.

4. Assess the tolerability of the hu14.18K322A at the MTD of the daily x4 and the weekly
dosing in patients with refractory or recurrent osteosarcoma.

Inclusion Criteria:

- Diagnosis: Recurrent or refractory neuroblastoma, osteosarcoma or melanoma.

- Age: < or equal to 21 years of age at the time of enrollment for patients with
melanoma or neuroblastoma; > or equal to 12 years of age for patients with

- 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

- 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 eligible provided they did
not experience a severe allergic reaction with the antibody.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibody, hu14.18K322A, in research participants with neuroblastoma, osteosarcoma or melanoma.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Fariba Navid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

June 2016

Related Keywords:

  • Neuroblastoma
  • Melanoma
  • Osteosarcoma
  • Melanoma
  • Neuroblastoma
  • Osteosarcoma



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794