Sarcoma
Conditions
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)
Interventions
DRUGAutologous CIK
Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory (4 dose levels)
Sponsors
Prof. Franca Fagioli
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
for part 1 * 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 Inclusion Criteria for part 2 * 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; * Pregnancy test should be negative 48 hours before treatment for post-pubertal women patients. All post-pubertal patients are to take adequate anti-contraceptive measures during treatment and until 8 weeks after the last dose of treatment.
Exclusion criteria
for part 1 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | 6 weeks | Incidence of dose-limiting toxicity (DLT) associated with CIK autologous cells administration |
Countries
Italy
Outcome results
None listed