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NCT01875601 · ClinicalTrials.gov registry record · Phase 1
NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01875601: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01875601 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875601, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
BACKGROUND: * Despite progress, some children and young adults with solid tumors still experience poor survival. * Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade procedures are available to generate large numbers of activated NK cells for adoptive cell therapy. OBJECTIVES: * Primary objectives are: 1) to assess the feasibility of harvesting and expanding activated NK cells to meet escalating dose goals in Cohort A, 2) to assess the toxicity of infusing escalating doses of activated NK cells following lymphodepleting chemotherapy without rhIL15 (cohort A), and 3) to assess the toxicity of infusing NK activated cells with escalating doses of rhIL15 (cohort B) in pediatric patients with refractory malignant solid tumors. * Secondary objectives are: 1) to identify biologically active doses of activated autologous NK cells plus or minus rhIL15 by monitoring changes in NK cell number, phenotype and function, 2) to assess pharmacokinetics and immunogenicity of rhIL15 in a pediatric population, and 3) assess antitumor effects and changes in FDG-PET following administration of activated NK cells to lymphopenic hosts plus or minus rhIL15. 4) to evaluate saftey and efficacy of subsequent cycles of autologous NK cell infusions in patients in cohort A who received benefit from the first NK cell infusion. ELIGIBILITY: * Patients in Cohort A: 2-29 years with with refractory pediatric malignant solid tumors, Patients in Cohort B: 2-25 years with refractory pediatric malignant solid tumors. * Adequate performance status and organ function, recovered from toxic effects of prior therapy, no requirement for systemic corticosteroids and no history of allogeneic stem cell transplantation. DESIGN: * All patients receive pre-NK lymphodepleting chemotherapy with cyclophosphamide. * Cohort A receives escalating doses of activated autologous NK cells to identify feasibility of generating cells and tolerability, and potentially identify an MTD. *
Interventions
- BIOLOGICAL Recombinant human interleukin-15 (rhIL-15)
- BIOLOGICAL NK Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-06-11 |
| Est. Completion | 2015-09-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01875601
The ClinicalTrials.gov registry entry for NCT01875601 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Recombinant human interleukin-15 (rhIL-15) is the first listed.
NCT01875601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01875601 about?
NCT01875601 is a clinical study titled "NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors". BACKGROUND: * Despite progress, some children and young adults with solid tumors still experience poor survival. * Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade procedures are available to generate large numbers of activated NK cells for adoptive cell therap...
What is the current status of trial NCT01875601?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2013-06-11. Estimated completion is 2015-09-08.
What interventions are being tested in trial NCT01875601?
The interventions under investigation include: Recombinant human interleukin-15 (rhIL-15) (BIOLOGICAL), NK Cell Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT01875601?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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