Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.

NCT04802070 | Completed Phase 1 DMC

• 1 other identifier: C.A.S.T.
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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)

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• DLT

  Incidence of dose-limiting toxicity (DLT) associated with CIK autologous cells administration

  6 weeks

Study Arms (1)

CIK

EXPERIMENTAL

Drug: Autologous CIK

Interventions

Autologous CIK DRUG

Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory (4 dose levels)

CIK

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with histologically documented unresectable sarcomas which progressed after first or further line treatments for relapsing disease who could be enrolled in Part 2 of study immediately or after a new line of treatment;
• Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if it depends solely on orthopedic problems)
• Estimated life expectancy \> 3 months;
• Adequate bone marrow functions:
• Signed informed consent;
• Negative serum or urine pregnancy test within 48 hours from collection of peripheral blood or from lympho cyto apheresis (if post-pubertal female patients);
• Archived histological tumour sample available
• Patients with histologically documented unresectable sarcomas which progressed after a first or further line treatments for relapsing disease
• Measurable disease (bone lesions are included);
• Karnofsky score ≥ 70% (patients with Karnofsky score ≥ 50% are eligible if its depend solely on orthopedic problems)
• Estimated life expectancy \> 3 months;
• Adequate bone marrow, hepatic and renal functionality
• Signed informed consent;
• Archived histological tumour sample available;
• Patients should have a venous central access;

You may not qualify if:

• History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection;
• Patients receiving chemotherapy and/or immunotherapy and/or anti-tumour agents and/or radiotherapy on more than 10% of bone marrow area two weeks before peripheral blood collection or lymphocytapheresis;
• Patients with neuro-psychiatric disorders or social or geographic problems that would prohibit the understanding or rendering informed consent and compliance with the requirements of this protocol are excluded.
• Patients with Ewing/Primitive Neuroectodermal Tumor Sarcoma, Rhabdomyosarcoma as well as other rapidly growing sarcomas are not to be included in the study;
• Presence of Central Nervous System metastases and/or meningeal neoplastic involvement;
• Patients with seizure disorders;
• Severe renal, vascular, cardiac, hepatic, lung disorders;
• Patients with any severe and/or uncontrolled medical conditions such as unstable angina pectoris, heart failure ≥ grade 2, a recent heart attack within 6 months, uncontrolled heart non arrhythmia uncontrolled metabolic disorders, cirrhosis, uncontrolled hypertension
• Patients with a non-optimal ex-vivo expansion of autologous CIK cells during Part 1 (\< 0.5 x 107/kg CIK cells);
• History of Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus or Hepatitis A Virus infection;
• Presence of bleeding disorders;
• Patients undergoing renal dialysis;
• Presence of uncontrolled diabetes
• Patients unable to swallow oral medications;
• Patients receiving concomitant steroid or immunotherapy (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency).

Sponsors & Collaborators

• Prof. Franca Fagioli: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Turin, 10126, Italy

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 17, 2021
• Study Start: January 11, 2021
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

IT (1)