Study of Ovarex® (Oregovomab) MAb With Front-Line Chemotherapy for Ovarian Cancer Treatment

Unither Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: oregovomab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00086632

OVA-Gy-18

Details and patient eligibility

About

An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.

Sex

Female

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III - IV, expressing the tumor-associated antigen CA125 as measured by a serum CA125 level ≥ 35 U/mL and tumor tissue which has been demonstrated by immunohistochemical methods to express CA125. All patients must provide primary tumor (and lymph node and ascites samples, if available) samples for cellular immunology assays and characterization
A functional performance status of ≤2 on the ECOG scale
Are randomized into the study no more than eight (8) weeks postoperatively
Have an expected survival of at least 6 months
Age less than or equal to 80 years of age
Be willing and able to comply with the protocol for the duration of the study
Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care

Exclusion criteria

Have received radiotherapy or chemotherapy
Have circumstances at the time of entry onto the protocol would not permit completion of study or require follow-up
Have other invasive malignancies, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
Have significant cardiovascular abnormalities [uncontrolled hypertension, Congestive Heart Failure (CHF) New York Heart Association (NYHA) Classes II-IV, see Appendix C), uncontrolled angina, myocardial infarction within the past six months or uncontrolled arrhythmias]. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months
Have an active autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring active immunosuppressive therapy
Have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug
Are being chronically treated with immunosuppressive drugs such as cyclosporin, Adrenocorticotrophic Hormone (ACTH), or systemic corticosteroids
Have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, congenital immunodeficiencies, Human Immunodeficiency Virus, or status post splenectomy
Have an uncontrolled disease (e.g. deteriorating renal function or nephropathy, active hepatitis, etc.) other than cancer. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible
Are taking mono-amine oxidase inhibitors or who have other contraindications to the use of pressor agents (e.g. epinephrine)
Are unable to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to surgery and prior to treatment Surgery
Patients will not be required to undergo second-look surgery (such surgery will be at the option of the investigator)
If patients undergo a second surgical procedure for a clinically indicated circumstance, an interval tumor sample with ascites and lymph node (if available) should be obtained, if present, for immunological evaluation and provided to the study tissue bank