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Fallopian Tubes CancerNCT01223235

Polyvalent Vaccine-KLH Conjugate + Opt-821 Given in Combination With Bevacizumab

A study testing bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in people with Fallopian Tubes Cancer and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Oct 2010to Sep 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically documented epithelial carcinoma arising in the ovary, fallopian tube or peritoneum.
  • Patients who have received cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen. Patients who received neoadjuvant chemotherapy are eligible.
  • Patients with relapsed ovarian, fallopian tube or primary peritoneal cancer who have now completed chemotherapy and/or surgery for recurrent disease. Eligible patients are those who would be appropriate to enter a period of observation if standard management were considered.
  • Patients who have asymptomatic residual measurable disease on CT scan or be in complete clinical remission. Patients may have an elevated CA-125. (Complete clinical remission is defined as serum CA-125 ≤ 35 IU/ml, negative physical examination and without objective evidence of disease by computed tomography (CT) of the abdomen and pelvis.)
  • Adequate hematologic, coagulation, renal and hepatic function.
  • ANC > = to 1,000 cells/mm3; platelets > or = 100,000 cells/mm3
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  • PT such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) Serum creatinine < or = to 1.5 mg/dl
  • Bilirubin, SGOT, Alk Phos < 2.5x upper limit normal
  • Urine protein : creatinine (UPC) ratio must be < 1 . If UPC ratio > 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study.
  • Karnofsky performance status > 70%
  • Expected survival of at least 4 months
  • Age ≥ 18 years. This protocol does not include children because the number of children with cancer is limited, and because a nationwide pediatric cancer research network already accesses the majority. Furthermore, the incidence of ovarian, fallopian tube, or peritoneal cancer in children is extremely infrequent.
  • Patients who are ≥ 4 weeks from completion of prior cytotoxic chemotherapy. Prior bevacizumab and/or immunotherapy treatment are permitted

Who cannot join

  • Inability to comply with study and/or follow-up procedures
  • Current or recent (within 4 weeks of the first infusion of this study) participation in another experimental drug study.
  • Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years
  • Patients must have undergone standard cytoreductive surgery as part of primary treatment to be eligible for this study and therefore are not of childbearing potential.Nursing mothers are excluded.
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
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  • New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix C)
  • History of myocardial infarction or unstable angina within 6 months prior to Day 1
  • History of stroke or transient ischemic attack within 6 months prior to Day 1
  • Known CNS disease, except for treated brain metastasis
  • Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
  • History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) or tumor involving major vessels.
  • Major surgical procedure such as laparotomy, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day
  • Patients with clinical symptoms or signs of GI obstruction who require parenteral hydration, parenteral nutrition, or tube feeding
  • Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Known hypersensitivity to any component of bevacizumab
  • Allergy to seafood
  • Active autoimmune disease (i.e. rheumatoid arthritis, ulcerative colitis etc); or immune deficiency (HIV, hypogammaglobulinemia); or known active infections with Hepatitis B or Hepatitis C; or those receiving immunosuppressive drugs (such as chronic systemic corticosteroids or cyclosporin, etc); or those receiving chronic antiinflammatory drugs (intermittent use of anti-inflammatory drugs is permitted).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A PILOT STUDY OF A POLYVALENT VACCINE-KLH CONJUGATE + OPT-821 GIVEN IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN SECOND OR GREATER COMPLETE OR PARTIAL CLINICAL REMISSION

The immune system of the body has the ability to fight and eliminate infections and cancers. Immune treatments, such as in this study, seek to teach the immune system to find and destroy cancer cells. The purpose of this study is to test whether it is safe to treat the cancer with a vaccine and another drug called bevacizumab (also known as Avastin).

Being tested
bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821
Keywords
FALLOPIAN TUBE, OVARY, PERITONEUM, BEVACIZUMAB (AVASTIN), GLOBO H-KLH CONJUGATE, MUC-1 KLH, OPT-821, TF (C) - KLH, TN(C)-KLH, 10-099
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821Biological

    A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.

Study groups in NCT01223235
Study groupRoleWhat they receive
bevacizumab & polyvalent vaccine-KLH conjugate + OPT-821ExperimentalThis is a single institution, open label, pilot study of bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Receives: Biological: bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events

    Toxicities evaluated by CTCAE version 4.0

    Measured: 1 year

Secondary outcomes (2)

  1. Percentage of Participants Who Met the Immunogenicity Criteria (>/=3 Antigens) of the Vaccine

    when given in the presence of bevacizumab

    Patients must have IgM titer >1:80, or a fourfold increase in prevailing antibody titer if present at baseline. Twenty-one patients would be accrued, and if >8 of 21 patients should meet these criteria for three or more antigens based on the immune response criteria, the study would be considered positive.

    Measured: 1 year

  2. Progression-free Survival as Assessed By Multiplex Biomarker Panel of Angiogenesis Markers

    Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5mm.

    Measured: Up to 24 months

Timeline

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

  1. First posted18 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionSep 2017
  4. Study completionSep 2017

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01223235
Sponsor's protocol ID
10-099
Status last verified
Sep 2017
First submitted
14 Oct 2010
Last updated
12 Jun 2018
Data monitoring committee
Yes

Publications

  • Kahn RM, Ragupathi G, Zhou QC, Iasonos A, Kravetz S, Hensley ML, Konner JA, Makker V, Tew WP, Aghajanian C, Sabbatini PJ, O'Cearbhaill RE. Long-term outcomes of patients with recurrent ovarian cancer treated with a polyvalent vaccine with bevacizumab combination. Cancer Immunol Immunother. 2023 Jan;72(1):183-191. doi: 10.1007/s00262-022-03225-1. Epub 2022 Jul 2.

    PubMed 35779095

Questions about this trial

What is this clinical trial studying?

A study testing bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821 in people with Fallopian Tubes Cancer and Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 13 inclusion and 23 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: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01223235, which also lists 1 linked publication.

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 12 Jun 2018.

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