Ovarian CancerPhase 2NCT00086632
Study of Ovarex® (Oregovomab) MAb With Front-Line Chemotherapy for Ovarian Cancer Treatment
A Phase 2 study testing oregovomab in people with Ovarian Cancer, run by Unither Pharmaceuticals.
Trial summary
An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. Read more about this study
- Who is it for?
- Ages Up to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- oregovomab
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to 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 Up to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III - IV, expressing the tumor-associated antigen CA125 as measured by a serum CA125 level ≥ 35 U/mL and tumor tissue which has been demonstrated by immunohistochemical methods to express CA125. All patients must provide primary tumor (and lymph node and ascites samples, if available) samples for cellular immunology assays and characterization
- A functional performance status of ≤2 on the ECOG scale
- Are randomized into the study no more than eight (8) weeks postoperatively
- Have an expected survival of at least 6 months
- Age less than or equal to 80 years of age
- Be willing and able to comply with the protocol for the duration of the study
- Have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Who cannot join
- Have received radiotherapy or chemotherapy
- Have circumstances at the time of entry onto the protocol would not permit completion of study or require follow-up
- Have other invasive malignancies, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
- Have significant cardiovascular abnormalities [uncontrolled hypertension, Congestive Heart Failure (CHF) New York Heart Association (NYHA) Classes II-IV, see Appendix C), uncontrolled angina, myocardial infarction within the past six months or uncontrolled arrhythmias]. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months
- Have an active autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring active immunosuppressive therapy
- Have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug
Show all 13Show fewer
- Are being chronically treated with immunosuppressive drugs such as cyclosporin, Adrenocorticotrophic Hormone (ACTH), or systemic corticosteroids
- Have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, congenital immunodeficiencies, Human Immunodeficiency Virus, or status post splenectomy
- Have an uncontrolled disease (e.g. deteriorating renal function or nephropathy, active hepatitis, etc.) other than cancer. Patients with chronic diseases that are well controlled (e.g., diabetes mellitus, hypertension) are eligible
- Are taking mono-amine oxidase inhibitors or who have other contraindications to the use of pressor agents (e.g. epinephrine)
- Are unable to read or understand, and/or unwilling to sign a written consent form which must be obtained prior to surgery and prior to treatment Surgery
- Patients will not be required to undergo second-look surgery (such surgery will be at the option of the investigator)
- If patients undergo a second surgical procedure for a clinically indicated circumstance, an interval tumor sample with ascites and lymph node (if available) should be obtained, if present, for immunological evaluation and provided to the study tissue bank
About this study
Official title: An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin
An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.
- Conditions
- Ovarian Cancer
- Being tested
- oregovomab
- Keywords
- oregovomab, ovarex, ovarian cancer, ovary, ovarian carcinoma, front-line
- Medical subject headings
- Ovarian Neoplasms
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.
- First posted9 Jul 2004 (estimated)
- Study startJul 2004
- Study completionDec 2007
Why it stopped: closed by sponser
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086632
- Sponsor's protocol ID
- OVA-Gy-18
- Status last verified
- Jan 2006
- First submitted
- 7 Jul 2004
- Last updated
- 18 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase II Study of Ovarex® MAb-B43.13 as an Adjuvant Treatment to Platinum-Based Front-Line Chemotherapy of Advanced Epithelial Carcinoma of Ovarian, Tubal, or Peritoneal Origin
- ClinicalTrials.gov ID
- NCT00086632
- Acronym / sponsor ID
- OVA-Gy-18
- Conditions
- Ovarian Cancer
- Keywords
- oregovomab, ovarex, ovarian cancer, ovary, ovarian carcinoma, front-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: closed by sponser
- Enrolment
- 40 participants
- Lead sponsor
- Unither PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An experimental treatment with OvaRex® MAb-B43.13 (oregovomab), called immunotherapy is being tested in ovarian cancer patients. Immunotherapy causes the body's defenses to react against cancer cells. The purpose of this research study is to determine if immunotherapy with oregovomab can create an immune response and enable the body to fight the disease and help ovarian cancer patients live longer. Patients with a possible diagnosis of ovarian cancer will be screened for study participation pre-surgery and, if eligible, will receive oregovomab during front-line chemotherapy treatment for ovarian cancer and quarterly for about a year following chemotherapy. Patients who experience disease progression will be discontinued from oregovomab therapy. Patients will also have urine, blood and tissue samples collected to assess the immune response to oregovomab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- A histologic diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III - IV, expressing the tumor-associated antigen CA125 as measured by a serum CA125 level ≥ 35 U/mL and tumor tissue which has been demonstrated by immunohistochemical methods to express CA125. All patients must provide primary tumor (and lymph node and ascites samples, if available) samples for cellular immunology assays and characterization
- A functional performance status of ≤2 on the ECOG scale
- Are randomized into the study no more than eight (8) weeks postoperatively
- Have an expected survival of at least 6 months
- Age less than or equal to 80 years of age
Key exclusion criteria (13 listed)
- Have received radiotherapy or chemotherapy
- Have circumstances at the time of entry onto the protocol would not permit completion of study or require follow-up
- Have other invasive malignancies, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix, who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
- Have significant cardiovascular abnormalities [uncontrolled hypertension, Congestive Heart Failure (CHF) New York Heart Association (NYHA) Classes II-IV, see Appendix C), uncontrolled angina, myocardial infarction within the past six months or uncontrolled arrhythmias]. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months
- Have an active autoimmune disease (e.g., rheumatoid arthritis, Systemic Lupus Erythematosus (SLE), ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring active immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oregovomab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: closed by sponser). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2007.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oregovomab in people with Ovarian Cancer, run by Unither Pharmaceuticals.
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 13 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.
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?
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.