Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
- Conditions
- Sarcoma
- Interventions
- Biological: Autologous CIK Dose level 2Biological: Autologous CIK Dose level 3Biological: Autologous CIK Dose level 1Biological: Autologous CIK Dose level 4
- Registration Number
- NCT03782363
- Lead Sponsor
- Italian Sarcoma Group
- Brief Summary
Monocentric, phase I study for advanced sarcoma with adoptive immunotherapy with Cytokine-Induced Killer (CIK).
In the first part of the study Patient's' peripheral blood will be collected and CIK cell expansion and storage will occur at the Regina Margherita Children's Hospital Cell Factory.
In the second part of the study the Maximum Tolerated Dose (MTD) will be determined in order to find the Recommended Dose for Phase II (RP2D)
- Detailed Description
In the first part of the study the patient's' peripheral blood collected from and CIK cell expansion and storage at the Regina Margherita Children's Hospital Cell Factory.
Approximately 40 patients will be enrolled in part 1 (range: 30 - 50 patients). The second part of the study will be a 3+3 dose escalation design to determine the MTD/RP2D.
A Safety Monitoring Committee (SMC) will be appointed to make dose escalation decisions.
Approximately 30 patients will be enrolled in this part (range: 6 - 36 patients).
Only one infusion of autologous CIK cells will be carried out at each cycle, every 21 days at the 1st, 2nd and 3rd dose levels and every 15 days at the 4th, 5th 6th dose levels.
A maximum of 6 cycles will be performed (patient with complete disease remission patients who benefit from treatment might also receive more cycles at the Investigator's discretion)
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Autologous CIK Dose level 2 Autologous CIK Dose level 2 autologous CIK at dose level 2 Autologous CIK Dose level 3 Autologous CIK Dose level 3 autologous CIK at dose level 3 Autologous CIK Dose level 1 Autologous CIK Dose level 1 autologous CIK at dose level 1 Autologous CIK Dose level 4 Autologous CIK Dose level 4 autologous CIK at dose level 4
- Primary Outcome Measures
Name Time Method Incidence of dose-limiting toxicity (DLT) associated with CIK autologous cells administration at week 6 The MTD will be determined through dose-escalation using a 3+3 cohort design. If less than oner third of evaluable patients in a given cohort (0 of 3 patients or 1 of 6 patients) experiences a DLT; escalation may proceed to the next higher dose level.
If one of the first 3 patients enrolled in a given cohort experiences a DLT, at least 3 additional patents will be enrolled in that cohort.
If a DLT is observed in one-third or more of patients, the dose at which this occurs will be considered not tolerated and the MTD will have been exceeded. The highest dose level(s) at which less than one-third of patients (0 of 3 patients or 1 of 6 patients) experiences a DLT will be declared the MTD and will be used as RP2D
- Secondary Outcome Measures
Name Time Method Progression free Survival At month 4 Survival free of disease progression
Plasma concentration of autologous CIK cells for pharmacokinetic At every cycle up to cycle 6 at: a) day 1 pre-dose b) 4 hours post-infusion, c) 24 hours post-infusion, d) day8 , e) day 15 Evaluation of the plasma concentration of autologous CIK cells to determine the pharmacokinetics parameter of the autologous CIK cells
Evaluation of Major histocompatibility complex class I-related chains A and B on tumor material pre-dose Major histocompatibility complex class I-related chains A and B expression in the tumor
Evaluation of UL16 binding proteins on tumor material pre-dose UL16 binding proteins expression in the tumor
Quality of live reported by the Patients Using European Organisation of Research and Treatment (EORTC) Quality of Life Questionnaire Questionnaire-Core 30 (QLQ-C30) at week 6 Evaluation of the quality of life during treatment
Trial Locations
- Locations (1)
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
🇮🇹Torino, Italy