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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 : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Quest PharmaTech Inc.

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 11, 2012
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE June 15, 2012
Actual Primary Completion Date June 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
Change in 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), Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approxmately 25 weeks after Cycle 1) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • 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.
  • 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.
  • 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]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2012)
  • Time to clinical relapse [ Time Frame: Study termination (approxmiately 25 weeks after Cycle 1) ]
    The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.
  • Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity) [ Time Frame: HAMA: screening, Cycle 3 (approx. 6 weeks after Cycle 1), Cycle 5 (approx. 12 weeks after Cycle 1), Cycle 5 plus 12 weeks (approx. 24 weeks after Cycle 1) DTH: screening and termination (approx. 25 weeks after Cycle 1) ]
    Laboratory test for (HAMA) human anti-mouse antibody 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.
  • Clinical response [ Time Frame: Up to three years after enrollment in the study ]
    Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]
  • Survival [ Time Frame: Up to three years after enrollment in the study ]
    The observed length of life from entry into the study to death or the date of last contact
  • Change in vital signs from baseline to end of study [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), Cycle 3 (approximately 6 weeks after Cycle 1), Cycle 5 (approximately 12 weeks after Cycle 1) and Cycle 5 plus 12 weeks (approxmately 24 weeks after Cycle 1) ]
    The following vital signs will be obtained: heart rate, respiratory rate, blood pressure, temperature
  • Change in clinical laboratory results from baseline to end of chemotherapy [ Time Frame: At Baseline (up to 4 weeks before Cycle 1), Cycle 3 (approximately 6 weeks after Cycle 1), Cycle 5 (approximately 12 weeks after Cycle 1), Cycle 5 plus 12 weeks (approxmately 24 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1) ]
    The following clinical laboratory results will be obtained: hematology (White Blood Cells [total count and differential], hemoglobin, hematocrit, Red Blood Cells), biochemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin [total], lactate dehydrogenase, protein, creatinine, urea, bicarbonate, chloride, potassium, sodium, calcium, phosphate, glucose, uric acid) and urinalysis (dipstick, pH, specific gravity, bilirubin, blood, protein, glucose, ketones, urobilinogen, microscopic evaluation)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Neoplasms
Intervention  ICMJE
  • Drug: Carboplatin
    carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days])
  • Drug: Paclitaxel
    Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])
  • Biological: oregovomab
    oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
    Other Name: OvaRex
Study Arms  ICMJE
  • Active Comparator: carboplatin & paclitaxel
    first-line chemotherapy for ovarian cancer
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: carboplatin & paclitaxel & oregovomab
    first-line chemotherapy for ovarian cancer plus oregovomab
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
    • Biological: oregovomab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2016)
97
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2012)
80
Actual Study Completion Date  ICMJE October 12, 2018
Actual Primary Completion Date June 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616303
Other Study ID Numbers  ICMJE QPT-ORE-002
2010-024305-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Quest PharmaTech Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Quest PharmaTech Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Woo, M.Sc. Quest PharmaTech Inc.
Study Chair: Christopher Nicodemus, MD FACP AIT Strategies
PRS Account Quest PharmaTech Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP