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Stage III Ovarian CancerPhase 2NCT01551745

Salvage Ovarian FANG™ Vaccine + Bevacizumab

A Phase 2 study testing Vigil™ Vaccine and Bevacizumab in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by Gradalis, Inc. 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
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Trial summary

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vigil™ Vaccine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Mar 2012to Apr 2016
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed papillary serous or endometrioid ovarian cancer.
  • Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or patients with vaccine prepared for CLPTL 105 but not otherwise qualifying.
  • Recurrent cisplatinum resistant/refractory disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements with no intervening therapy.
  • Successful manufacturing of 4 vials of Vigil™ vaccine.
  • Recovered from all clinically relevant toxicities related to prior therapies.
  • ECOG PS 0-2 prior to Vigil™ vaccine administration.
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  • Normal organ and marrow function as defined below:
  • Absolute granulocyte count ≥1,500/mm3
  • Absolute lymphocyte count ≥ 200/mm3
  • Platelets ≥100,000/mm3
  • Total bilirubin ≤1.5 x ULN
  • AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤2.5 x ULN
  • Creatinine <1.5 mg/dL
  • INR < 1.5
  • Baseline blood pressure must be under 140/90
  • Urine protein-to-creatinine ratio < 1.0 mg/dL.
  • Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  • Ability to understand and the willingness to sign a written informed protocol specific consent.

Who cannot join

  • Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
  • Major surgery within 6 weeks or minor surgery within 2 weeks of receiving bevacizumab.
  • Patient must not have received any other investigational agents within 4 weeks prior to study entry.
  • Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
  • Patients with history of brain metastases.
  • Patients with compromised pulmonary disease.
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  • Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
  • Prior splenectomy.
  • Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  • Kaposi's Sarcoma.
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding such as a known bleeding disorder, coagulopathy, or tumor involving major blood vessels.
  • History of Stroke/Transient Ischemic Attack
  • Use of bleeding diathesis
  • Use of anti-coagulants
  • Patients with clinically significant cardiovascular disease including any of the following:
  • Significant cardiac conduction abnormalities (e.g., PR interval > 0.24 sec or second or third degree AV block.
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg.
  • Myocardial infarction, cardiac arrhythmia, or unstable angina within the past 6 months.
  • New York Heart Association grade II or greater congestive heart failure.
  • Serious cardiac arrhythmia requiring medication.
  • Grade II or greater peripheral vascular disease except episodes of ischemia < 24 hours induration that are managed non-surgically and without permanent deficit
  • History of cerebrovascular accident within the past 6 months.
  • No significant traumatic injury within the past 28 days.
  • Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with known HIV.
  • Patients with chronic Hepatitis B and C infection.
  • Patients with uncontrolled autoimmune diseases.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75230

Other trials in United States

About this study

Official title: Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Bevacizumab for Patients With Recurrent/Refractory Ovarian Cancer Participating in Study CL-PTL 105

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Being tested
Vigil™ Vaccine, Bevacizumab
Keywords
Papillary Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Epithelial Ovarian 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.

  • Vigil™ VaccineBiological

    Also called bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™

    Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

  • BevacizumabDrug

    Also called VEGF

    Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Study groups in NCT01551745
Study groupRoleWhat they receive
Vigil™ VaccineExperimentalPatients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
Receives: Biological: Vigil™ Vaccine; Drug: Bevacizumab

What is being measured

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

  1. Time to Progression

    Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

    Measured: 24 months

  2. Response Rate

    Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Number of Alive Subjects

    Survival status of patients after treatment was determined by following these patients up to 24 months.

    Measured: 24 months

  2. Enzyme-Linked ImmunoSorbent Spot (ELISPOT)

    To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.

    Measured: Baseline, End of Treatment (30 days after last dose) up to 12 months

Timeline

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

  1. First posted13 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01551745
Sponsor's protocol ID
CL-PTL 112
Status last verified
Oct 2021
First submitted
1 Mar 2012
Last updated
19 Oct 2021
Data monitoring committee
Yes

Publications

  • Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

    PubMed 22186789

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vigil™ Vaccine and Bevacizumab in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by Gradalis, Inc. 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 18 inclusion and 27 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 19 Oct 2021. 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.

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?

Yes. Results are posted in the registry (first posted 1 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?

Time to Progression (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT01551745, 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 19 Oct 2021.

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