Persistent or relapsing ovary epithelial cancer
Conditions
Interventions
Scheme used for scaling-up dosage of 188Re/Ior C5 MAb. 188Re/Ior C5 MAb will be administered 7 to 14 days after diagnosis study is completed. One single 3-5mg dose of MAb will be given transperitoneal
Antibodies, Monoclonal
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients who have previously been on well established onco-specific treatments and therapies. 2) Patients giving their consent in writing to participate in the trial. 3) Patients whose previous immunogammagraphic studies with 99mTc-iorc5 (7-14 days before treatment) showed positive images and 4-quadrant permeability. 4) Patients aged 18 to 70. 5) Karnofsky Coefficient = 60. 6) Patients whose life expectancy is > 3 months. 7)Patients with organs and bone marrow working normally, in keeping with the following parameters: Hemoglobin >= 10 g/L, Total leucocytes >= 4x109 cells/L, Absolute neutrophil count >= 1,500/uL, Platelet count >= 100x109/L, Total bilirubin: within normal limits, TGP and TGO: = 2.5 times the institutional higher normal value, Serum creatinine = 132mmol/L, Urea and Glycemia: within normal limits for each institution. 8) Female patients will be included in the trial.
Exclusion criteria
Exclusion criteria: 1) Pregnancy and/or breastfeeding. 2) Patients with severe acute diseases. 3)Patients on previous abdominal radiant therapy preventing the immunogammagraphic study with 99mTc-ior c5 for 4-quadrant permeability confirmation. 4) Patients on another concurrent onco-specific treatment (PQT, external radiotherapy, immunotherapy, etc.). 5) Patients with another concomitant cancer. 6) Patients with fever due to acute infectious diseases. 7)Patients with history of severe allergies or uncontrolled chronic diseases, such as ischemic cardiopathy, bronchial asthma, diabetes mellitus, high blood pressure, etc. 8) Patients who have previously been on murine MaB therapy. 9) Coagulation disorders. 10) Local sepsis in the area to be treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum permissible dose and toxicity, measuring time: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, pharmacokinetics, biodistribution, dosage, HAMA effect, immunogenicity, antitumoral effect, measuring time: 12 months. | — |
Countries
Cuba
Contacts
Public ContactDr. Angel Casaco Parada
Center of Molecular Immunology (CIM)
Outcome results
None listed