NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors (NCT01875601) | Clinical Trial Compass
CompletedPhase 1
NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors
United States16 participantsStarted 2013-06-11
Plain-language 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.
* A1: 1x10(6) NK cells/kg
* A2: 1 x 10(7) NK cells/kg
* A3: 1 x 10(8) NK cells/kg
* If feasibility and acceptable toxicity is demonstrated for all doses in Cohort A, patients enrolled on cohort B will receive activated autologous NK cells plus escalating doses of rhIL15 using the following schema:
* B1: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10
* B2: 1 x 10(7) NK cells/kg + rhIL15 0.5 mcg/kg/d IV x 10
* B3: 1 x 10(7) NK cells/kg + rhIL15 1 mcg/kg/d IV x 10
* B4: 1 x 10(7) NK cells/kg + rhIL15 2 mcg/kg/d IV x 10
* Three patients will be enrolled at each dose level, with the dose level expanded to 6 if dose-limiting toxicity occurs. An expanded group of 12 patients will be treated at the highest tolerable dose level. DLT toxicity monitoring will continue for 21 days after the NK infusion, or 14 days after the last rhIL15 dose in Cohort B (whichever is later).
Who can participate
Age range
2 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Diagnosis:
* Histologically confirmed solid tumors, including primary brain tumors. In subjects with brain stem or optic gliomas the requirement for histological confirmation may be waived.
* Age: Cohort A: 2 to less than or equal to 29 years old at the time of enrollment. Cohort B: 2 to less than or equal to 25 years old at the time of enrollment.
* Patients must have evaluable or measurable malignant disease at enrollment.
* Prior Therapy:
* The patient s malignancy must have relapsed after or failed to respond to frontline curative therapy and/or there must not be any potentially curative treatment options available at the time of study entry.
* There is no limit to the number of prior treatment regimens. However, patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study enrollment. Acute toxicity of any previous therapy must have resolved to grade 1 or less, unless specified elsewhere. Myelosuppressive chemotherapy: Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment (6 weeks if prior nitrosourea).
* Hematopoietic growth factors: At least 7 days must have elapsed since the completion of therapy with a growth factor. At least 14 days must have elapsed after receiving pegfilgrastim.
* Biologic (anti-neoplastic agent) or metronomic non-myelosuppressive chemotherapy: At least 7 days must have elapsed since the completion of therapy with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a completed Phase 1 trial that was specifically measuring toxicity and feasibility rather than effectiveness, what do the published results tell us about whether NK white blood cell therapy with interleukin was considered safe enough to move forward — and has it led to a follow-up Phase 2 study?
2My child has been diagnosed with an advanced solid tumor — given that this trial focused on children and young adults with conditions like neuroblastoma, sarcoma, and brain tumors, does their specific diagnosis and how far the cancer has progressed match the type of patients who were actually enrolled?
3Because this trial used NK cells alongside interleukin, which is a immune-stimulating drug, what kinds of side effects were most commonly reported, and how serious were they in the children who participated?
4Since this trial is already completed and no longer enrolling, are there any currently open trials building on this NK cell approach that might be worth considering for my child's situation?
5Before exploring experimental approaches like this NK cell therapy, is there a standard treatment pathway we should try first, or has my child's cancer reached a point where a trial like this would have been the more appropriate option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.