AzTrials
AzTrials

Ovarian NeoplasmsPhase 1/2NCT00034138

A Comparative Pharmacokinetics and Safety Study of OvaRex MAb-B43.13 in Patients With Ovarian Epithelial Carcinoma

A Phase 1/2 study testing oregovomab in people with Ovarian Neoplasms, run by Unither Pharmaceuticals at 8 sites in United States.

Terminated

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

Official record
Search all trials

Trial summary

The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
oregovomab
How many people
24 participants
Where
8 sitesUnited States
Study dates
Mar 2002to Dec 2007
Phase
Phase 1/2
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 to 65 years
  • 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.
  • FIGO Stage III or IV prior to study.
  • Serum CA125 level >35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level > or = 100 U/mL following surgery or immunohistochemical evidence of tumor tissue expressing CA125.
  • Completed primary treatment following initial diagnosis, including chemotherapy involving a cisplatin or carboplatin-based regimen.
  • Functional Performance Status < or = 2 by ECOG scale.
  • Medical assessment consistent with prognosis for an expected survival of at least 3 months.
  • Voluntary participation, signed informed consent and willingness to complete all study procedures.

Who cannot join

  • No surgery (not including minor surgical procedures), chemotherapy, or radiotherapy (whole abdomen, abdominopelvic or pelvic) within 4 weeks prior to first dose of study drug.
  • No known refractory or recurrent disease requiring chemotherapy during the 4 weeks prior to, or planned 10 weeks after first study dose.
  • Serum CA125 levels not >800 U/mL at baseline evaluation.
  • No gross (clinically evident) ascites.
  • No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 4 weeks of first study dose.
  • No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes or serum human anti-murine antibodies (HAMA) not above upper limit of normal at baseline evaluation.
Show all 22Show fewer
  • Not on long-term chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
  • Ovarian tumors must be of low malignant potential or with noninvasive disease.
  • 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 known allergy to murine proteins, or prior documented anaphylactic reaction to any drug, or known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
  • No previous splenectomy.
  • No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn's Disease, MS, ankylosing spondylitis).
  • 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.
  • No significant cardiovascular abnormalities including uncontrolled hypertension, uncontrolled angina, uncontrolled arrhythmias, or CHF (NYHA Classes II-IV).
  • No compromised hematopoietic function defined as a hemoglobin <10.0 g/dL or lymphocyte count <300 mm3 or neutrophil count <1000 mm3 or platelet count <100,000 mm3.
  • No hepatic dysfunction defined as a bilirubin above upper limit of normal, LDH, SGOT and SGPT >2 times upper limits of normal, or albumin <3.5 g/dL.
  • No renal dysfunction defined as serum creatinine above upper limit of normal.
  • No pregnancy or breast-feeding (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.)
  • No other investigational drugs within 30 days of enrollment.
  • No contraindications present to the use of pressor agents.
  • No HIV infection, or recent history of drug abuse, alcoholism, or hepatitis.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37920

  • Women's Cancer Research Foundation

    Miami, Florida, 33143

  • Mary Babb Randolph Cancer Center

    Morgantown, West Virginia, 26506

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32804

  • Magee-Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • St. Joseph's Medical Center

    South Bend, Indiana, 46634

Other trials in United States

About this study

The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.

Read the detailed description

This is a prospective, open-label, randomized, parallel group, Phase 1/2 study in female patients with Stage III/IV epithelial ovarian cancer. The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. The study will also evaluate the safety of the cell culture product and the immune responses in patients following treatment. The study is being conducted in three phases:

  1. The pharmacokinetic assessment phase will include at least 24 patients, who will be randomized into two treatment groups to receive a single 2 mg dose of either ascites fluid product or cell culture product.
  2. The treatment phase will continue administration of two more monthly doses (weeks 4 and 8) and all patients will receive cell culture product. Study patients will be followed for safety and immune response through week 20.
  3. The continuation phase will continue administration of cell culture product at the discretion of the investigator on a quarterly schedule for up to 104 weeks in eligible patients who tolerate therapy. Patients who continue treatment will be followed for serious adverse events and all patients will be followed for survival for up to 2 years after first treatment.
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 posted24 Apr 2002 (estimated)
  2. Study startMar 2002
  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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00034138
Sponsor's protocol ID
OVA-Gy-16
Status last verified
Dec 2007
First submitted
23 Apr 2002
Last updated
18 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing oregovomab in people with Ovarian Neoplasms, run by Unither Pharmaceuticals at 8 sites in United States.

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 22 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 8 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 NCT00034138.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in