Ovarian carcinoma (FIGO stage IIIA and IIIB/IIIC/IV
Conditions
Interventions
Product Name: Human MHC non-restricted cytotoxic T-cell line
Product Code: TALL-104
Pharmaceutical Form: Intraperitoneal solution
INN or Proposed INN: TALL-104 cells
Other descriptive name: TALL-104
C
Sponsors
Galileo Research Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis of ovarian carcinoma FIGO stage IIIA and IIIB/IIIC/IV -Patients not eligible for treatment with Bevacizumab -Minimal or microscopic residual disease at second look laparotomy/laparoscopy (patients with extra-abdominal disease will be excluded by the study unless those with pleural effusion). Microscopic residual disease is defined as positive cytology washing and/or positive random biopsies at 2nd look, while minimal residual disease is defined as tumour lesion/lesions of diameter =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1. Evidence of extraperitoneal metastatic disease. 2. Clinically significant cardiovascular, hepatic, gastrointestinal, haematological or psychiatric diseases as judged by the Investigator. 3. HIV infection. 4. Medical conditions requiring steroid administration. 5. Chemotherapy within the previous four weeks. 6. Serum Creatinine > 1.5 mg/dl. 7. Absolute neutrophil count < 1,500/mm3 and platelets < 100,000/mm3 . 8. Use of other investigational drugs/treatments, or enrolment in a clinical study within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of repeated intraperitoneal administrations of TALL-104 in patients affected by ovarian carcinoma.;Secondary Objective: Evaluate: -safety of TALL-104 after repeated intraperitoneal administration; -kinetics of TALL-104 cells in peripheral blood by PCR or karyotyping; -immunological monitoring (human autologous anti-TALL-104 antibodies, anti-BSA antibodies and cellular response against TALL-104 cells); -tumour markers. ;Primary end point(s): To evaluate the conversion rate from minimal/microscopic residual disease to pathological complete response. ;Timepoint(s) of evaluation of this end point: Pathological complete response evaluated at third look laparoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate: -safety of TALL-104 after repeated intraperitoneal administration; -kinetics of TALL-104 cells in peripheral blood by PCR or karyotyping; -immunological monitoring (human autologous anti-TALL-104 antibodies, anti-BSA antibodies and cellular response against TALL-104 cells); -tumour markers ;Timepoint(s) of evaluation of this end point: 1. safety: from the screening visit (Visit 0) to the last Follow up visit. 2. kinetics: from Visit 1 to Visit 15 of each course of treatment. 3. immunological monitoring: from Visit 1 to the last Follow up visit. 4. tumour markers evaluation: from Visit 1 to the last Follow up visit. | — |
Countries
Italy
Contacts
Public ContactProject Management Department
CROMSOURCE srl
Outcome results
None listed