Solid TumorsPhase 1NCT01875601
NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors
A Phase 1 study testing Recombinant human interleukin-15 (rhIL-15) and NK Cell Infusion in people with Solid Tumors and Brain Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 29 years
- Conditions the study is for
- Solid Tumors, Brain Tumors, Sarcoma
- What is being tested?
- Recombinant human interleukin-15 (rhIL-15) and NK Cell Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2013to 8 Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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 a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur.
- Monoclonal antibodies: At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody.
- Radiotherapy: 3 weeks must have elapsed since XRT
- Performance status: ECOG 0, 1 or 2, or for children less than or equal to10 years of age, Lansky greater than or equal to 60. Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
- Cardiac function: Left ventricular ejection fraction greater than or equal to 45% or fractional shortening greater than or equal to28%.
- Liver function: Serum total bilirubin < 2 mg/dl, serum AST and ALT less than or equal to 3 x upper limit of normal. Patients with Gilbert syndrome are excluded from the requirement of a normal
- bilirubin. (Gilbert syndrome is found in 3-10% of the general population, and is characterized by mild, chronic unconjugated hyperbilirubinemia in the absence of liver disease or overt hemolysis). On cohort B, patients with liver involvement by tumor will not be eligible due to potential confounding risk for hepatotoxicity when rhIL15 is administered. NOTE: adult values will be used for calculating hepatic toxicity on this trial, as is standard on POB phase I trials.
- Renal function: Age-adjusted normal serum creatinine according to the following table or a creatinine clearance greater than or equal to 60 ml/min/1.73 m(2).
- Age (years) <TAB><TAB><TAB>Maximum serum creatinine (mg/dl)
- less than or equal to5 <TAB><TAB>0.8
- >5 less than or equal to 10 <TAB> 1.0
- >10 less than or equal to 15 <TAB>1.2
- > 15 <TAB><TAB><TAB><TAB>1.5
- Marrow function: ANC must be > 750/mm(3) (unless due to underlying disease in which case there is no grade restriction), platelet count must be greater than or equal to 75,000/mm(3) (not achieved by transfusion). Lymphopenia, CD4 lymphopenia, leukopenia, and anemia will not render patients ineligible.
- Female patients (and when relevant their male partners) must be willing to practice birth control (including abstinence) during and for two months after treatment, if of childbearing potential.
- Ability to give informed consent. For patients <18 years of age their legal guardian must give informed consent. Pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent.
- Durable power of attorney form offered (patients greater than or equal to18 years of age only).
- Both men and women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Untreated CNS metastatic disease as defined by:
- Solid Tumors: History of untreated metastatic CNS tumor involvement. Extradural masses which have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement are eligible IF the CNS tumor(s) has been treated and has been stable or resolving for at least 4 weeks; and if the patient does not currently require steroids.
- Prior history allogeneic stem cell transplantation.
- Breast feeding or pregnant females (due to risk to fetus or newborn).
- HIV or HTLV-I/II (due to unacceptable risk associated with severe immune suppression and risk associated with cell products).
- Hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive with elevated liver transaminases. All patients with chronic active hepatitis (including those on antiviral therapy) are ineligible.
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- Patients who require systemic corticosteroid or other systemic immunosuppressive therapy. Immunosuppressive therapy must be stopped at least 28 days prior to enrollment. Topical agents and/or inhaled corticosteroids are permitted.
- High risk of inability to comply with therapy in the estimation of the PI.
- Clinically significant systemic illness (e.g. serious active infections or significant vital other organ dysfunction), that in the judgment of the PI would likely compromise the patient s ability to tolerate protocol therapy or significantly increase the risk of complications.
- Prior history of pericarditis or pericardial effusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Study of Autologous Activated Natural Killer (NK) Cells +/- rhIL15 in Children and Young Adults With Refractory 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 therapy.
Read more
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).
Read the detailed description
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).
- Conditions
- Solid Tumors, Brain Tumors, Sarcoma, Pediatric Cancers, Neuroblastoma
- Being tested
- Recombinant human interleukin-15 (rhIL-15), NK Cell Infusion
- Keywords
- NK Cells, Cytokine, Lymphodepleting Chemotherapy, Immunotherapy, Pediatric
- Medical subject headings
- Brain Neoplasms, Sarcoma, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human interleukin-15 (rhIL-15)Biological
Continuous infusion rhIL15 IV
NK Cell InfusionBiological
Infuse expanded NK cells at Day 0 after 2 days of Cyclophosphamide lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | NK cell infusion (dose escalation) Receives: Biological: NK Cell Infusion |
| B | Experimental | NK cell infusion + escalating doses of rhIL15 Receives: Biological: Recombinant human interleukin-15 (rhIL-15); Biological: NK Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Assess the toxicity of infusing escalating doses of autologous artificial APC activated and expanded NK cells following lymphodepleting chemotherapy without rhIL15 in patients with recurrent or refractory pediatric solid tumors.
Measured: 1 month
Feasibility
Assess the feasibility of harvesting and expanding activated NK cells to meet escalating dose goals in Cohort A
Measured: 1 month
Secondary outcomes (1)
Antitumor activity
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start11 Jun 2013
- Primary completion8 Sep 2015
- Study completion8 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rosandra N Kaplan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875601
- Sponsor's protocol ID
- 130152
- Other IDs
- 13-C-0152
- Status last verified
- 11 Feb 2026
- First submitted
- 11 Jun 2013
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Publications
Kontny HU, Hammerle K, Klein R, Shayan P, Mackall CL, Niemeyer CM. Sensitivity of Ewing's sarcoma to TRAIL-induced apoptosis. Cell Death Differ. 2001 May;8(5):506-14. doi: 10.1038/sj.cdd.4400836.
PubMed 11423911Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. doi: 10.1056/NEJMoa0911123.
PubMed 20879881Dudley ME, Rosenberg SA. Adoptive-cell-transfer therapy for the treatment of patients with cancer. Nat Rev Cancer. 2003 Sep;3(9):666-75. doi: 10.1038/nrc1167.
PubMed 12951585
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Autologous Activated Natural Killer (NK) Cells +/- rhIL15 in Children and Young Adults With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01875601
- Acronym / sponsor ID
- 130152
- Conditions
- Solid Tumors, Brain Tumors, Sarcoma, Pediatric Cancers, Neuroblastoma
- Keywords
- NK Cells, Cytokine, Lymphodepleting Chemotherapy, Immunotherapy, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Jun 2013
- Primary completion
- 8 Sep 2015 (actual)
- Study completion
- 8 Sep 2015 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: NK Cell InfusionNK cell infusion (dose escalation) |
| B | Experimental | Biological: Recombinant human interleukin-15 (rhIL-15), Biological: NK Cell InfusionNK cell infusion + escalating doses of rhIL15 |
Who may qualify
- Ages
- 2 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (26 listed)
- 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:
Key exclusion criteria (10 listed)
- Untreated CNS metastatic disease as defined by:
- Solid Tumors: History of untreated metastatic CNS tumor involvement. Extradural masses which have not invaded the brain parenchyma or parameningeal tumors without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous CNS tumor involvement are eligible IF the CNS tumor(s) has been treated and has been stable or resolving for at least 4 weeks; and if the patient does not currently require steroids.
- Prior history allogeneic stem cell transplantation.
- Breast feeding or pregnant females (due to risk to fetus or newborn).
- HIV or HTLV-I/II (due to unacceptable risk associated with severe immune suppression and risk associated with cell products).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human interleukin-15 (rhIL-15)Continuous infusion rhIL15 IV | Biological | B |
| NK Cell InfusionInfuse expanded NK cells at Day 0 after 2 days of Cyclophosphamide lymphodepletion | Biological | A, B |
Primary outcome
Toxicity
Time frame: 1 month
Assess the toxicity of infusing escalating doses of autologous artificial APC activated and expanded NK cells following lymphodepleting chemotherapy without rhIL15 in patients with recurrent or refractory pediatric solid tumors.
Feasibility
Time frame: 1 month
Assess the feasibility of harvesting and expanding activated NK cells to meet escalating dose goals in Cohort A
1 secondary outcome
Antitumor activity
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 11423911Kontny HU, Hammerle K, Klein R, Shayan P, Mackall CL, Niemeyer CM. Sensitivity of Ewing's sarcoma to TRAIL-induced apoptosis. Cell Death Differ. 2001 May;8(5):506-14. doi: 10.1038/sj.cdd.4400836.
- Background: PubMed 20879881Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. doi: 10.1056/NEJMoa0911123.
- Background: PubMed 12951585Dudley ME, Rosenberg SA. Adoptive-cell-transfer therapy for the treatment of patients with cancer. Nat Rev Cancer. 2003 Sep;3(9):666-75. doi: 10.1038/nrc1167.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosandra N Kaplan, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant human interleukin-15 (rhIL-15) and NK Cell Infusion in people with Solid Tumors and Brain Tumors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875601, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.