Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT02173093
Eligibility Criteria:
The study is now in the phase II expansion phase.
Inclusion Criteria for phase II:
* The target tumor is limited to neuroblastoma and the diagnosis should be histologically verified.
* Patients must have refractory or recurrent malignancy; patient's current disease state must be one for which no known curative therapy is available;
* Patients should not receive any other experimental or phase 1 therapy within 3 weeks prior to study enrollment and monoclonal antibody therapy within 6 weeks
* To be eligible for phase I study patients should have primary refractory or relapsed disease as evidenced by:
* Local tumor recurrence measurable on CT or magnetic resonance imaging (MRI) scans with or without metastatic lesions
* Refractory bone marrow involvement in patients with NB
* NB with MIBG-positive skeletal lesions
* The presence of radiographically measurable disease immediately prior to start of Phase I immunotherapy is not an eligibility requirement in the following situations:
* In patients with NB who have documented bone marrow (BM) involvement;
* In patients with NB who have MIBG-positive bony lesion(s);
* An additional eligibility requirement for phase II study includes the presence of radiographically measurable disease with the exception of MIBG-positive NB or NB with bone marrow involvement:
* Patients must have a Lansky or Karnofsky performance status score of \>= 70
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
* Myelosuppressive chemotherapy: must not have received within 3 weeks of starting immunotherapy (IT)
* Hematopoietic growth factors: at least 7 days since the last dose of growth factor therapy
* Immunotherapy: at least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody
* Normal organ function
* All patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are postmenarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 3 months after the last dose of GD2Bi-aATC; breastfeeding women should be excluded
* Patients who have an uncontrolled infection are not eligible
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Months
Maximum Age:
29 Years
Study:
NCT02173093
Study Brief:
Protocol Section:
NCT02173093