Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults

Who is this study for? Patients with Melanoma
What treatments are being studied? Cord Blood-derived Expanded Allogeneic Natural Killer Cells+Cyclophosphamide+Etoposide
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This phase I trial studies the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells (donor natural killer \[NK\] cells) and how well they work when given together with cyclophosphamide and etoposide in treating children and young adults with solid tumors that have come back (relapsed) or that do not respond to treatment (refractory). NK cells, white blood cells important to the immune system, are donated/collected from cord blood collected at birth from healthy babies and grown in the lab. Drugs used in chemotherapy, such as cyclophosphamide and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NK cells together with cyclophosphamide and etoposide may work better in treating children and young adults with solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 40
Healthy Volunteers: f
View:

• SCREENING: Patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life.

• SCREENING: Patients older than 21 years must have a solid tumor considered by study doctor to be of the childhood cancer type.

• SCREENING: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age.

• SCREENING: Documentation of measurable or evaluable non-measurable disease.

• SCREENING: At least one documented histological verification of solid tumor diagnosis. Can be from original diagnosis or more recent.

• ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from the clinically significant acute treatment-related toxicities of all prior treatments prior to beginning treatment on this protocol with exceptions of cytopenias resulting from persistent disease, hearing loss and alopecia.

• ENROLLMENT: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age.

• ENROLLMENT: Creatinine clearance \>= 60 mL/min/1.73m\^2 (calculated by 24 hour \[h\] urine collection or nuclear glomerular filtration rate \[GFR\] scan if 24 h collection is not possible) or a serum creatinine based on age and gender as follows:

⁃ Age, maximum serum creatinine (mg/dL):

∙ 1 month to \< 6 months, male 0.4, female 0.4;

‣ 6 months to \< 1 year, male 0.5, female 0.5;

‣ 1 to \< 2 years, male 0.6, female 0.6;

‣ \>= 16 years, male 1.7, female 1.4.

• ENROLLMENT: Adequate liver function, defined as: total bilirubin =\< 2 mg/dl

• ENROLLMENT: Adequate liver function, as defined as serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's disease or abnormal liver function due to primary disease).

• ENROLLMENT: Evidence of adequate bone marrow function (defined by absolute neutrophil count \>= 750), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function.

• ENROLLMENT: Evidence of adequate bone marrow function (defined by platelets \>= 50,000), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function.

• ENROLLMENT: Pulmonary symptoms controlled by medication and pulse oximetry \>= 92% on room air.

• ENROLLMENT: Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized).

• ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens.

• ENROLLMENT: Signed informed consent and if applicable pediatric assent.

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Demetrios Petropoulos, MD
dpetro@mdanderson.org
713-792-3746
Time Frame
Start Date: 2018-08-31
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 38
Treatments
Experimental: Treatment (cyclophosphamide, etoposide, NK cells)
Patients receive cyclophosphamide IV QD over 30 minutes and etoposide IV QD over 60 minutes on days 1-5 in the absence of unacceptable toxicity. Patients then receive cord blood derived allogeneic NK cells IV on day 8.
Authors
Jessica S. Foglesong, Sajad J. Khazal, Jessica A. Foglesong
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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