Status:
COMPLETED
A Phase I Trial Of The Humanized Anti-GD2 Antibody In Children And Adolescents With Neuroblastoma, Osteosarcoma, Ewing Sarcoma and Melanoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Evan T.J. Dunbar Neuroblastoma Foundation
Duke University
Conditions:
Neuroblastoma
Melanoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
Relapsed and/or refractory neuroblastoma, osteosarcoma, Ewing sarcoma and melanoma are considered difficult to treat and cure. For this study we are testing the use of a new experimental (investigatio...
Detailed Description
SJGD2 is a Phase I dose finding study. The primary purpose of this phase I study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity of the humanized monoclonal anti-GD2 antibo...
Eligibility Criteria
Inclusion
- Diagnosis:
- Part A: Recurrent or refractory neuroblastoma or melanoma.
- Part B: Recurrent or refractory neuroblastoma or melanoma.
- Part C: Recurrent or refractory osteosarcoma and Ewing sarcoma.
- Age: ≤ 21 years of age at the time of enrollment (i.e. participants are eligible until they reach their 22nd birthday).
- Does not have a clinically significant neurologic deficit or objective peripheral neuropathy (greater than or equal to grade 2). Peripheral (sensory or motor) neuropathy related to limb sparing procedure or amputation is allowed.
- 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.
- 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. Steroid containing inhalers, steroid replacement for adrenal insufficiency and steroid premedication for prevention of transfusion or imaging contrast agent-related allergic reaction will be permitted.
- 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
- 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.
Key Trial Info
Start Date :
October 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00743496
Start Date
October 8 2008
End Date
April 18 2014
Last Update
August 17 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105