Sarcoma MedDRA version: 20.0 Level: PT Classification code 10039491 Term: Sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Antonio Pérez-Martínez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 0 and 30 years diagnosed with malignant sarcoma, who continue to present detectable residual disease (based on imaging techniques) at the end of conventional treatment. 2. Lansky / Karnofsky Index> 60%. 3. Functional alteration of organs (liver, renal, respiratory) mild-moderate ( 39%. 5. Adult subjects who have voluntarily signed informed consent prior to the first study intervention. 6. Minors whose legal representative / guardian has voluntarily signed informed consent prior to the first study intervention. 7. In the case of mature minors (12-17 years of age), in addition to the consent signed by the legal guardian, the child's consent will be obtained. 8. Women with reproductive capacity should have a negative pregnancy test at the time of inclusion and should be given access to highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implantation , Injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their participation in the study and within 30 days after the last visit. 9. Presence of a compatible haploident donor (parent or sibling). Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Patients with a history of poor therapeutic compliance. 2. Patients who, after a psycho-social evaluation, are censored as unfit for the procedure: • Socio-familial situation that makes it impossible to participate correctly in the study. • Patients with emotional or psychological problems secondary to the disease such as posttraumatic stress disorder, phobias, delusions, psychosis, requiring specialist support. • Evaluation of family involvement in the patient's health. • Inability to understand test information. 3. Functional alteration of organs (severe hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 4.3). 4. The contraindications, interactions, precautions for use and dose reductions indicated in the relevant technical data sheets should be considered. 5. Subjects who have been given other investigational drugs within 90 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of immunotherapy with haploidenic allogeneic NK cells and IL-2, following lymphoblative chemotherapy and / or radiotherapy (2Gy) in the tumor, in pediatric patients with refractory sarcoma.;Secondary Objective: 1. To analyze the incidence of episodes of febrile neutropenia, bacteremia, infections (viral, fungal), hematologic recovery and hospital admission associated with treatment with NK + IL-2 cells. 2. Evaluate the rate of disease progression five years after treatment with NK + IL-2 cells. 3. Determine the expression of NK cell ligands in both solid and serum tumor samples from patients with sarcoma. To correlate these results with the progression of the disease to identify new prognostic biomarkers.;Primary end point(s): Safety of infusion of haploidenic allogeneic adult differentiated NK cells in combination with IL-2 after chemotherapy and radiotherapy;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 36 months;Secondary end point(s): 1. Incidence of episodes of febrile neutropenia, bacteremia, infections (viral, fungal), hematological recovery and hospital admission associated with treatment. 2. Five-year progression rate of disease following treatment with NK + IL-2 cells. This will be determined by imaging techniques. 3. Expression levels of inhibitory / activating ligands of NK cells in samples from solid and serum tumors of patients. These will be determined by immunohistochemistry and PCR techniques | — |
Countries
Spain
Contacts
Public ContactUCICEC
Hospital Universitario La Paz
Outcome results
None listed