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Ovarian NeoplasmsPhase 2NCT00034372

Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma

A Phase 2 study testing oregovomab in people with Ovarian Neoplasms, run by Unither Pharmaceuticals at 17 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration. Group 1 will receive two doses, one month apart. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
oregovomab
How many people
102 participants
Where
17 sitesin 2 countries
Study dates
Sep 2000to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and disease is classified as FIGO Stage III or IV.
  • Functional Performance Status < or = 2 by ECOG scale or > or = 60% on Karnofsky scale.
  • Medical assessment consistent with prognosis for an expected survival of at least 6 months.
  • Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL and immunohistochemical evidence of tumor tissue expressing CA125.
  • Presence of residual disease that is either (a) visible to or palpable by the surgeon at the completion of the staging laparotomy procedure, or (b) microscopic disease remaining following the staging laparotomy procedure.
  • Received chemotherapy that included cisplatin or carboplatin following appropriate staging procedure.
  • Complete clinical response to primary treatment protocol, which included laparotomy followed by platinum-based adjuvant chemotherapy.

Who cannot join

  • First dose of study medication must be within 10 weeks of completing last dose of primary chemotherapy.
  • Not more than one prior regimen of chemotherapy. A change of 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.
  • No whole abdomen, abdominopelvic or pelvic radiotherapy, surgery or chemotherapy within 4 weeks prior to first dose of study drug.
  • No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 6 weeks of first study dose. Patients who have received hemopoietic factors are acceptable.
  • No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes.
  • No compromised hematopoietic function defined as a hemoglobin <8.0 g/dL or lymphocyte count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3.
Show all 24Show fewer
  • No hepatic dysfunction defined as a bilirubin >1.5 times the upper normal limits.
  • No severe renal dysfunction defined as serum creatinine >1.6 mg/dL.
  • While pregnancy is unlikely in view of the disease and previous surgery, patients who the investigator considers may be at risk of pregnancy will have a pregnancy [beta-HCG] test and will be using a medically approved contraceptive method. Patients who are breast-feeding are also excluded.
  • No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn?s Disease, MS, ankylosing spondylitis).
  • No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug.
  • Not on chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
  • No active infection causing fever.
  • No previous splenectomy.
  • No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies.
  • No uncontrolled diseases or illness other than this cancer. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible.
  • No significant cardiovascular abnormalities (uncontrolled hypertension, CHF (NYHA Classes II-IV), uncontrolled angina, or uncontrolled arrhythmias).
  • No concurrent illness or chronically taking medication that could confound the results of the study, preclude the patient from completing the study or mask an adverse reaction.
  • No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for > or = 5 years.
  • No other investigational drugs within 30 days of enrollment.
  • No contraindications present to the use of pressor agents.
  • Inability to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to treatment.
  • Only tumors of low malignant potential or with noninvasive disease.
  • Not more than one interval debulking procedure.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States12 sites

  • Parker Hill Oncology & Hematology

    Boston, Massachusetts, 02120

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37920

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32804

  • Swedish Medical Center Tumor Institute

    Seattle, Washington, 98104

  • St. Joseph's Regional Medical Center

    South Bend, Indiana, 46617

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

Canada5 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • SMBD Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E O9V

Other trials in Canada

About this study

In this study, patients will be randomized to one of three dose regimen groups. Each dose of OvaRex MAb-B43.13 is 2 mg by slow intravenous administration.

Group 1 will receive two doses, one month apart.

Read more

Group 2 will receive three consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 9 doses.

Group 3 will receive six consecutive monthly doses, then at 12-week intervals through 2 years or until disease relapse up to a total of 11 doses.

The study will compare the time to disease relapse of patients who demonstrate an immune response to OvaRex MAb-B43.13 with time to disease relapse of those who do not demonstrate an immune response to OvaRex MAb-B43.13. Differences in the percentage of patients demonstrating an immune response in each dose regimen group will also be assessed.

Being tested
oregovomab
Keywords
immunotherapy, monoclonal, antibody, Stage III ovarian epithelial cancer, Stage IV ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oregovomabDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2002 (estimated)
  2. Study startSep 2000
  3. Study completionDec 2007

Why it stopped: closed by sponser

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
102 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00034372
Sponsor's protocol ID
OVA-Gy-15
Status last verified
Dec 2007
First submitted
26 Apr 2002
Last updated
18 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oregovomab in people with Ovarian Neoplasms, run by Unither Pharmaceuticals at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: closed by sponser). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00034372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2007.

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