Trial Search Results

A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel) alone in female patients with advanced ovarian cancer. This study is to confirm previous results that showed oregovomab was able to help the body to produce an immune response to CA125 (a target that has been identified on ovarian cancer cells) in patients with stage III-IV ovarian cancer when they were receiving chemotherapy for their disease. The primary aim of the study is to see how well these patients with advanced ovarian cancer make an immune response to CA125 by using a specific test (enzyme-linked immunospot (ELISPOT) assay) of the patient's blood. The study will also look at the side effects of the oregovomab, other immune response parameters, how well the patients respond to the treatment of their disease (how long it takes to show that their disease has progressed and how long these patients survive overall).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Quest PharmaTech Inc.

Intervention(s):

  • Drug: Carboplatin & paclitaxel
  • Biological: Carboplatin & paclitaxel & oregovomab

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin
   and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage
   III/IV disease.

   - have preoperative CA125 levels > 50 U/mL

   - have optimal cytoreduction (RT=0)

   - be anticipated to have first-line 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/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1.
   Platelets greater than or equal to 100,000/µL; 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)

   - able to sign informed consent and provide authorization permitting release of personal
   health information

   - have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

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,
   lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum
   glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin <3.5 g/dL

   - have severe renal insufficiency with serum creatinine >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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting