Trial Search Results

Clinical Trial for Ovarian Cancer (OvaRex®)

This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Unither Pharmaceuticals

Stanford Investigator(s):

Intervention(s):

  • Drug: oregovomab

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian,
   tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV.
   Histological diagnosis must have been confirmed by site pathology review of slides as
   documented by the site investigator. These slides must be made available for sponsor
   review.

   - Patients must have had an elevated serum CA125 level (per reference lab normal range)
   measured prior to or at surgery (i.e., not later than the immediate post-surgery
   period when the patient is in the surgical recovery room). If a pre-surgical CA125
   measurement is not available, then the patient must have had: (a) a serum CA125 level
   ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical
   methods to express CA125.

   - Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third
   cycle of front-line chemotherapy.

   - Patients must have had microscopic or small diameter residual disease following
   primary de-bulking surgical procedure.

   - Patients must have received chemotherapy that included a platinum compound and a
   taxane following appropriate staging procedures. Front-line treatment can include no
   more than 8 cycles of chemotherapy.

   - Patients must have had a complete clinical response to their front-line surgery and
   chemotherapy. A complete clinical response is defined as one in which the patient had
   a normal physical examination, no conclusive evidence of residual tumor by CT of the
   abdomen and pelvis, a normal chest x-ray, and a serum CA125 level at least 5 U/mL but
   less than 35 U/mL as measured in the pretreatment baseline laboratories by the
   protocol Central Lab.

   - Patients must have undergone no more than one interval de-bulking procedure.

   - Patients must receive their first dose of study medication between 4 and 12 weeks
   after completing their last dose of front-line chemotherapy.

   - Patients must have voluntarily agreed to participate and have signed the informed
   consent, and are willing to complete all study procedures.

Exclusion Criteria:

   - Patients who have received more than one prior regimen of chemotherapy. A change in
   chemotherapy agents is permitted during the patient's primary therapy provided that
   the change is considered to be part of the initial chemotherapy treatment regimen.

   - Patients with known refractory or recurrent epithelial adenocarcinoma of ovarian,
   tubal, or peritoneal origin requiring chemotherapy.

   - Patients who have compromised hematopoietic function (hemoglobin <8.0 g/dL; lymphocyte
   count <300 mm³; neutrophil count <1000 mm³; platelet count <100,000 mm³.

   - Patients with hepatic dysfunction defined as a bilirubin >1.5 times the upper normal
   limits, LDH, SGOT and SGPT>2 times upper limits of normal or albumin <3.5 g/dL.

   - Patients with severe renal dysfunction defined as a serum creatinine >1.6 mg/dL.

   - Patients with a known allergy to murine proteins or have had a documented anaphylactic
   reaction to any drug, or a known hypersensitivity to diphenhydramine or other
   antihistamines of similar chemical structure.

   - Patients who have contraindications to the use of pressor agents.

   - Patients being chronically treated with immunosuppressive drugs such as cyclosporin,
   ACTH, or systemic corticosteroids.

   - Patients who have received immunotherapy (interferons, tumor necrosis factor, other
   cytokines [e.g., interleukins] or biological response modifiers, or BCG vaccines)
   within 6 weeks of receiving their first dose of study medication. Patients who have
   received hemopoietic factors are acceptable.

   - Patients who have had a splenectomy.

   - Patients with uncontrolled diseases other than cancer will be excluded. Patients with
   chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are
   eligible.

   - Patients who have a concurrent illness or chronically taking medication, which would
   confound the results of the study, preclude the patient from completing the study, or
   mask an adverse reaction.

   - Patients who have a concurrent malignancy (except non-melanoma of the skin, in situ
   carcinoma of cervix), unless the patient received curative treatment and has been
   disease free for greater than or equal to 5 years.

   - Patients receiving other investigational drugs within 30 days of enrollment.

Ages Eligible for Study

18 Years - N/A

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
Jim Batterson
6507255974
Not Recruiting