188Re-marked Ior C5 MAb in persistent or relapsing ovary epithelial cancer, phase I.

Phase 1

• Conditions: Persistent or relapsing ovary epithelial cancer; Ovarian Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine Gland Neoplasms; Adnexal Diseases; Ovarian Diseases; Genital Diseases, Female; Female Urogenital Diseases; Gonadal Disorders

• Registration Number: RPCEC00000036
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 15

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum permissible dose and toxicity, measuring time: 12 months.

Secondary Outcome Measures

Name	Time	Method
Adverse events, pharmacokinetics, biodistribution, dosage, HAMA effect, immunogenicity, antitumoral effect, measuring time: 12 months.