Relapsed or refractory extracranial solid tumors in children and adolescents.
Conditions
Interventions
Product Name: Alocelyvir
Product Code: Alogenic bone marrow stem adult mesenchymal cells
Pharmaceutical Form: Infusion
INN or Proposed INN: Alogenic bone marrow stem adult mesenchymal cells expanded
Sponsors
Fundación de Investigación Biomédica Hospital Niño Jesús
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 1 year and =21 years. 2. Patients with extra-cranial solid tumor, relapsed or refractory, for which there is no standard curative treatment. 3. Disease measurable or evaluable according to RECIST criteria v1.1. 4. Patients for whom the combination with the proposed chemotherapy and radiotherapy regimens is considered adequate. Patients may have previously received the same schemes. 5. Adequate functional status, organic function (renal, hepatic) and hematological values: o Functional status: Lansky =50% and Karnofsky =50%. Patients who use a wheelchair due to paralysis associated with the tumor will be considered ambulatory for the assessment of functional status. o Haematological function (dose confirmation phase): ? Platelets =75,000 / µL (without support for 3 days). ? Total neutrophils =750 / µL (without growth factor for 3 days). ? Hemoglobin = 8 g / dL (transfusions allowed). o Haematological function (expansion phase): ? Platelets =50,000 / µL (without support for 3 days). ? Total neutrophils =500 / µL (without growth factor for 3 days). ? Hemoglobin = 8 g / dL (transfusions allowed). o Kidney and liver function: ? Serum creatinine =1.5 times the high value of normality. In case of creatinine> 1.5 times the high value of normality, glomerular filtration (estimated by Schwartz, cystatin or other methods)> 60 ml / min / 1.73 m2. ? Total bilirubin =1.5 times the high value of normality. ? Transaminases (GOT and GPT) =3 times the high value of normality. In case of patients with liver metastases =5 times the high value of normal. 6. Patient capable of complying with the treatment and plan of visits and evaluations. 7. Life expectancy =3 months. 8. Appropriate contraceptive methods for sexually active men and women of childbearing age. 9. Negative pregnancy test for women of childbearing age. 10. Informed consent in writing according to current legislation. 11. Washing periods compared to previous treatments. o At least two weeks of the last dose of chemotherapy. For patients receiving metronomical oral chemotherapy at low doses, this period is at least one week. o At least four weeks after the autologous hematopoietic stem cell transplant. o At least three months after the allogeneic transplant of hematopoietic progenitors. Patients will only be able to enter if they do not have clinically significant active complications derived from the transplant. o At least two weeks after the last focal radiotherapy or six weeks in the case of craniospinal radiation therapy. There is no washing for palliative radiotherapy. Radiotherapy may be part of the treatment of the trial in which case the treatment with Alo-Celyvir will be applied as described in section 6. o At least two weeks or 5 half-lives (whichever occurs earlier) since the last dose of a biological or investigational treatment. Are the trial subjects under 18? yes Number of subjects for this age range: 24 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
Exclusion criteria
Exclusion criteria: 1. Previous treatment with Celyvir. 2. Active acute toxicities of previous treatment grade =3 of the CTCAE v4. 3. Known and uncontrolled bacterial, viral, fungal or parastaria active infection. 4. Known active infection for hepatitis or HIV virus. 5. Patients with CNS metastases should be clinically stable and with stable or decreasing doses of steroids for at least one week. 6. Serious active and past systemic diseases that are clinically significant or uncontrolled, which may imply an added risk for the patient. 7. Allergy to Penicillin or its derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •Expansion phase: To measure antitumor activity (measured as objective response rate [complete response and partial response]) of the combination). •Feasibility of the combination. •Antitumor activity (dose confirmation phase). •Security (Expansion phase). •Calculation of progression-free survival. •Calculation of global survival.;Timepoint(s) of evaluation of this end point: 4 weeks;Main Objective: Dose confirmation phase: to evaluate the safety of the combination of AloCelyvir added to the cytoreductor scheme (combination of chemotherapy, surgery, radiotherapy).;Primary end point(s): •Dose confirmation phase: Rate of dose-limiting toxicities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Expansion phase: Rate of objective responses (complete and partial responses) of the combination. •Feasibility of the combination: rate of patients who meet selection criteria who can receive at least one cycle of the combination of Alo-Celyvir with chemo-radiotherapy and measurement of the time from recruitment to the preparation and administration of Alo-Celyvir. •Dose confirmation phase: Rate of objective responses (complete and partial responses) of the combination. •Progression free survival. •Global survival. •Rate of adverse events.;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Countries
Spain
Contacts
Public ContactMaría Eugenia Flores Ruiz
Hospital Universitario de La Princesa
Outcome results
None listed