Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma. MedDRA version: 13.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Oregovomab
Product Code: MAb-B43.13
Pharmaceutical Form: Powder for infusion
Current Sponsor code: MAb-B43.13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
QUEST PHARMATECH INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • be between 18 and 75 years old. • have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and FIGO Stage III/IV disease. • have preoperative CA125 levels > 100 U/mL. • have optimal cytoreduction (RT=0). • be anticipated to have chemotherapy infusion within 6 weeks after surgery. • be available to complete the protocol for the duration of the study. • have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/?l, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/?l; hemoglobin greater than or equal to 8.0 g/dL. • have adequate Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1. • have adequate Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1). • sign informed consent and authorization permitting release of personal health information. • have an ECOG Performance Status of 0 or 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn`s Disease, multiple sclerosis (MS), ankylosing spondylitis). • have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or cannot tolerate cyclophosphamide. • are being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids. • have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia. • have an acquired, hereditary, or congenital immunodeficiency. • have uncontrolled diseases other than cancer. • have contraindications to the use of pressor agents. • have undergone more than one surgical debulking. • have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, LDH, SGOT and SGPT doubled compared to normal or albumin 1.6 mg/dL. • have concomitant diseases or treatments that may confound the results of the study, which may preclude the completion of the protocol or may mask adverse reactions. • are to be tested with other medications during treatment. • are unable to read or understand or unable to sign the necessary written consent before starting treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Confirm and clarify the preliminary results of Braly8 on the induction of CA125-specific cellular immunity of clinical relevance with Oregovomab infusion associated with first-line chemotherapy in patients with stage III-IV ovarian cancer. The primary objective of the clinical trial is the evaluation of anti CA125 cellular immune response by ELISPOT assay.;Secondary Objective: The secondary objectives are to evaluate safety, other immunological parameters, response rate, time to clinical relapse and survival in the treatment groups.;Primary end point(s): evaluation of anti CA125 cellular immune response by ELISPOT assay. | — |
Countries
Italy
Outcome results
None listed