Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01616303
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Quest PharmaTech Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: carboplatin & paclitaxel Biological: carboplatin & paclitaxel & oregovomab Phase 2

Detailed Description:

Oregovomab is an investigational drug previously used in clinical trials as an immunotherapeutic treatment of ovarian cancer patients whose tumor cells express the tumor associated antigen, CA125. The active component of oregovomab is the activated murine monoclonal antibody B43.13, an immunoglobulin G1k (IgG1k) subclass immunoglobulin that binds with high affinity (1.16E10/M) to CA125.

CA125 is a surface glycoprotein antigen that is expressed on more than 80% of all non-mucinous epithelial ovarian carcinomas where it occurs at elevated levels in the serum of patients with ovarian cancer. Little is known about its biological function. CA125 is associated with a large molecular weight mucin-like glycoprotein complex of 200-250 kilodaltons (kDa) and its genetic structure has recently been elucidated. There is good evidence to suggest that CA125 is a relevant target antigen for antigen-mediated immunotherapy of ovarian cancer.

The study will 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma
Actual Study Start Date : June 15, 2012
Actual Primary Completion Date : June 15, 2015
Actual Study Completion Date : October 12, 2018


Arm Intervention/treatment
Active Comparator: carboplatin & paclitaxel
first-line chemotherapy for ovarian cancer
Drug: carboplatin & paclitaxel
carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])
Other Names:
  • Abraxane
  • paclitaxel
  • carboplatin

Experimental: carboplatin & paclitaxel & oregovomab
first-line chemotherapy for ovarian cancer plus oregovomab
Biological: carboplatin & paclitaxel & oregovomab
carboplatin (AUC 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]) plus paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days]) plus oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
Other Names:
  • Abraxane
  • palictaxel
  • carboplatin
  • oregovomab




Primary Outcome Measures :
  1. CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1) ]
    Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy


Secondary Outcome Measures :
  1. Time to clinical relapse [ Time Frame: Up to three years after treatment in the study ]
    The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.

  2. Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity) [ Time Frame: Up to three years after treatment in the study ]
    Laboratory test for human anti-mouse antibody (HAMA) present in patients' sera. DTH (delayed type hypersensitivity) is an on-site test conducted by the investigator by injecting a small amount of the Oregovomab product and three other antigens (mumps, tetanus, and Candida) into the skin of the patient and observing the effects.

  3. Clinical response [ Time Frame: Up to three years after treatment in the study ]
    Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]

  4. Overall Survival [ Time Frame: Up to three years after treatment in the study ]
    The observed length of life from entry into the study to death or the date of last contact



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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<1)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616303


Locations
Layout table for location information
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Indiana
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Sponsors and Collaborators
Quest PharmaTech Inc.
Investigators
Layout table for investigator information
Study Director: Thomas Woo, M.Sc. Quest PharmaTech Inc.
Study Chair: Christopher Nicodemus, MD FACP AIT Strategies

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Quest PharmaTech Inc.
ClinicalTrials.gov Identifier: NCT01616303     History of Changes
Other Study ID Numbers: QPT-ORE-002
2010-024305-13 ( EudraCT Number )
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quest PharmaTech Inc.:
ovarian
cancer
neoplasm
adenocarcinoma
CA125
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Oregovomab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs