Primary Ovarian CancerPhase 1NCT02452775
Autologous OC-L Vaccine and Ovarian Cancer
A Phase 1 study testing OC-L, Montanide and poly-ICLC (Hiltonol), in people with Primary Ovarian Cancer and Fallopian Tube Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- OC-L, Montanide and poly-ICLC (Hiltonol),
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 30 May 2018
- Phase
- Phase 1
- 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
- Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer FIGO stage III or IV defined surgically at the completion of initial abdominal surgery.
- Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment.
- Subject has no evidence of disease based on radiographical imaging
- Subject has appropriate tissue available from the cytoreductive surgery tumor lysate preparation.
- Lysate must meet release criteria.
- Subject is 18 years of age or older.
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- Subject has an ECOG performance status of ≤ 2.
- Subject understood and signed the study specific informed consent.
- Subjects screened between 1 to 12 weeks after last cycle of chemotherapy.
- Subjects screened any time after completed last cycle of chemotherapy till progression or first recurrence of the disease.
- Subject has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing.
- Subjects who screen fails can be re-enrolled if the causation of the screen fail has been corrected.
Who cannot join
- Subject for whom tumor lysate does not meet release criteria
- Subject has a positive serum Yo antibody (Does not need to be repeated if performed in the past)
- Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
- Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
- Subject has positive test result at the screening visit for one or more of the following:
- HTLV-1/2
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- Anti-HIV 1 Antibody (α-HIV-1)
- Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.
- Subject has renal insufficiency as defined by a serum creatinine > 2.2 mg/dl or BUN > 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
- Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study
- Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 3X the upper limits of normal.
- Subject has hematopoietic failure at baseline as defined by one of the following:
- Platelets < 100,000/ mm3
- WBC < 2,500/mm3
- Absolute Neutrophil Count (ANC) < 1,000/mm3
- Absolute lymphocyte count < 200/ mm3
- Hematocrit < 30%
- Subject has any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
- Subject has a serious, non-healing wound, ulcer, or bone fracture.
- Subject has a clinically significant cardiovascular disease including:
- Uncontrolled hypertension;
- Myocardial infarction or unstable angina within 6 months prior to enrollment
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- Subject has a grade II or greater peripheral vascular disease.
- Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
- Subject has any underlying conditions, which would contraindicate therapy with study treatment
- Subject has organ allografts.
- Subject is receiving medication(s) that might affect immune function. Use of H2 antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine. However, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ovarian Cancer Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Pilot Trial to Test the Addition of Montanide and Polyiclc to Autologous Oxidized Tumor Cell Lysate Vaccine in Combination With Gmcsf in Primary Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Being tested
- OC-L, Montanide, poly-ICLC (Hiltonol),
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC-LBiological
MontanideOther
poly-ICLC (Hiltonol),Other
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects in ARM 1 will receive the vaccination with OC-L alone Receives: Biological: OC-L |
| Arm 2 | Experimental | subjects in ARM 2 will receive vaccination with OC-L admixed with Montanide, Receives: Other: Montanide |
| Arm 3 | Experimental | subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol) Receives: Other: poly-ICLC (Hiltonol), |
| Arm 4 | Experimental | subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC. Receives: Biological: OC-L; Other: Montanide; Other: poly-ICLC (Hiltonol), |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of Adverse Events
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2015
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ovarian Cancer Research Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452775
- Sponsor's protocol ID
- UPCC 40814
- Status last verified
- Apr 2020
- First submitted
- 21 May 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Trial to Test the Addition of Montanide and Polyiclc to Autologous Oxidized Tumor Cell Lysate Vaccine in Combination With Gmcsf in Primary Advanced Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02452775
- Acronym / sponsor ID
- UPCC 40814
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Ovarian Cancer Research Center
- Study start
- May 2015 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 25 May 2015 (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.
This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: OC-LSubjects in ARM 1 will receive the vaccination with OC-L alone |
| Arm 2 | Experimental | Other: Montanidesubjects in ARM 2 will receive vaccination with OC-L admixed with Montanide, |
| Arm 3 | Experimental | Other: poly-ICLC (Hiltonol),subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol) |
| Arm 4 | Experimental | Biological: OC-L, Other: Montanide, Other: poly-ICLC (Hiltonol),subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer FIGO stage III or IV defined surgically at the completion of initial abdominal surgery.
- Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment.
- Subject has no evidence of disease based on radiographical imaging
- Subject has appropriate tissue available from the cytoreductive surgery tumor lysate preparation.
- Lysate must meet release criteria.
Key exclusion criteria (28 listed)
- Subject for whom tumor lysate does not meet release criteria
- Subject has a positive serum Yo antibody (Does not need to be repeated if performed in the past)
- Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
- Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
- Subject has positive test result at the screening visit for one or more of the following:
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 |
|---|---|---|
| OC-L | Biological | Arm 1, Arm 4 |
| Montanide | Other | Arm 2, Arm 4 |
| poly-ICLC (Hiltonol), | Other | Arm 3, Arm 4 |
Primary outcome
Numbers of Adverse Events
Time frame: 3.5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OC-L, Montanide and poly-ICLC (Hiltonol), in people with Primary Ovarian Cancer and Fallopian Tube Cancer, run by Abramson Cancer Center at Penn Medicine 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 12 inclusion and 28 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 24 Apr 2020. 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 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.
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. 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.
What does the primary outcome measure?
Numbers of Adverse Events (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
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 24 Apr 2020.