Ovarian CancerPhase 1/2NCT01312389
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase 1/2 study testing OC-L/Montanide ISA 51 VG, Ampligen and Prevnar in people with 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 Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- OC-L/Montanide ISA 51 VG, Ampligen and Prevnar
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 17 Aug 2012
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer and has already received front line platinum based chemotherapy prior to recurrence.
- Subject has had prior secondary cytoreductive surgery yielding tumor for Lysate preparation.
- Lysate must meet release criteria.
- Subject has a current largest tumor nodule that is >1 cm CT or MRI.
- Subject is 18 years of age or older.
- Subject has an ECOG performance status of <1.
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- Subject has a life expectancy of >6 months.
- Subject must understand and sign the study specific informed consent.
- Subject may have received chemotherapy or other therapy after harvest of tumor and prior to enrollment but must have recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less).
- Subject may have received prior investigational therapy (including immune therapy).
- Subject may have received prior hormonal therapy.
- Subject may have received prior radiation therapy but must have completed such therapy prior to enrollment.
- Subject 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
- Subject has a chronic or acute hepatitis C infection.
- Subject has a chronic or acute hepatitis B infection.
- Subject has positive test result at the screening visit for one or more of the following: 1. HTLV-1/2 Antibody, 2. Anti-HIV 1/2 Antibody
- 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.
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- Subject has renal insufficiency as defined by a serum creatinine > 2.2 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 50 ml/min.
- 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 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 known allergies to reagents used in this study.
- Subject has organ allograft.
- Subject is receiving medications that might effect 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.
- Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or requires parenteral hydration and/or nutrition.
- Subject has hematopoietic failure at baseline as defined by one of the following:
- Platelets<100,000/mm 3
- WBC < 2,500/mm3
- Absolute Neutrophil Count (ANC) < 1,500/mm3
- Absolute lymphocyte count <200/mm 3
- Hematocrit < 30%
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.
Read the detailed description
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months. This study has two Phases eligible subjects enrolled in Phase 1 will receive the OC-L admixed with Montanide ISA 51 with intravenous Ampligen. Subjects enrolled in Phase II will be randomized to two ARMS. This randomized design will allow for the unbiased evaluation and comparison of immune response among the 2 treatment arms. patients will be randomized (10 per treatment arm) in blocks of size 4 or 6, such that treatment assignment will be balanced after each group of 4 or 6 patients has been randomized. ARM A 10 patients will receive OC-L. Arm b 10 patients will receive OC-L with Ampligen. Following each vaccination, subjects in Phase I and Arm B will be given intravenous Ampligen 3 times starting 2-3 days after each vaccine administration. All subjects will receive vaccine on Day 0, 14, 28, 42 and 56. Subjects will receive Prevnar on day 0 and day 14. Subjects will be treated till exhaustion of OC-L or disease progression whichever occurs first subjects will be contacted every 6 months for up to 5 years and then annually for survival. The OC-L study product is manufactured and quality tested at Cell and Vaccine Production Facility and then released to IDS, where it will be admixed with Montanide ISA 51 VG on day of vaccination.
- Being tested
- OC-L/Montanide ISA 51 VG, Ampligen, Prevnar
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OC-L/Montanide ISA 51 VGBiological
All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.
AmpligenBiological
All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.
PrevnarBiological
A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Arm A | Experimental | 10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions. Receives: Biological: OC-L/Montanide ISA 51 VG; Biological: Prevnar |
| Phase 2: Arm B | Experimental | 10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen. Receives: Biological: OC-L/Montanide ISA 51 VG; Biological: Ampligen; Biological: Prevnar |
| Phase 1 | Experimental | 3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2. Receives: Biological: OC-L/Montanide ISA 51 VG; Biological: Ampligen; Biological: Prevnar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 4.0). All toxicities observed within 30 days of last vaccination will be included. All patients that receive at least one vaccination will be included in the toxicity analysis.
Measured: within 30 days of last vaccination
Secondary outcomes (2)
Immune Response
Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLA-A2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a > 3 fold increase relative to pre-vaccination.
Measured: within 30 days of vaccination
Clinical Response
Clinical Response will be estimated using immune related response criteria ir(RC)
Measured: within 30 days of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completion17 Aug 2012
Why it stopped: Did not meet criteria laid out in Phase 1 to continue to Phase 2
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 1/2
- 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
- Responsible party
- Sponsor
- Investigators
- Janos Tanyi, MD, Ph.D, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312389
- Sponsor's protocol ID
- UPCC 29810
- Status last verified
- Oct 2021
- First submitted
- 1 Mar 2011
- Last updated
- 15 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01312389
- Acronym / sponsor ID
- UPCC 29810
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not meet criteria laid out in Phase 1 to continue to Phase 2
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- 17 Aug 2012 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Posted 15 Nov 2021
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 Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months.
Detailed description
This is a Phase I/II randomized study for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-L, an autologous vaccine comprised of autologous Oxidized tumor Cell Lysate (OC-L) administered by intradermal/subcutaneous injection in combination with Ampligen (poly-l:poly-C12U), a Toll-like receptor 3 agonist. Study duration is 24 months. This study has two Phases eligible subjects enrolled in Phase 1 will receive the OC-L admixed with Montanide ISA 51 with intravenous Ampligen. Subjects enrolled in Phase II will be randomized to two ARMS. This randomized design will allow for the unbiased evaluation and comparison of immune response among the 2 treatment arms. patients will be randomized (10 per treatment arm) in blocks of size 4 or 6, such that treatment assignment will be balanced after each group of 4 or 6 patients has been randomized. ARM A 10 patients will receive OC-L. Arm b 10 patients will receive OC-L with Ampligen. Following each vaccination, subjects in Phase I and Arm B will be given intravenous Ampligen 3 times starting 2-3 days after each vaccine administration. All subjects will receive vaccine on Day 0, 14, 28, 42 and 56. Subjects will receive Prevnar on day 0 and day 14. Subjects will be treated till exhaustion of OC-L or disease progression whichever occurs first subjects will be contacted every 6 months for up to 5 years and then annually for survival. The OC-L study product is manufactured and quality tested at Cell and Vaccine Production Facility and then released to IDS, where it will be admixed with Montanide ISA 51 VG on day of vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Arm A | Experimental | Biological: OC-L/Montanide ISA 51 VG, Biological: Prevnar10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions. |
| Phase 2: Arm B | Experimental | Biological: OC-L/Montanide ISA 51 VG, Biological: Ampligen, Biological: Prevnar10 patients will receive vaccine (OC-L, an autologous vaccine comprised of autologous oxidized tumor cell lysate, admixed with Montanide ISA 51 VG) injected by intradermal/subcutaneous injection in both groin regions, administered in combination with intravenous Ampligen. |
| Phase 1 | Experimental | Biological: OC-L/Montanide ISA 51 VG, Biological: Ampligen, Biological: Prevnar3 patients will be enrolled receiving the vaccine (tumor lysate/Montanide) plus Ampligen using a 3+3 approach. If no DLTs in the first three subjects, we will move to phase II; if one 1/3 subject develops DLTs, we will enroll 3 additional subjects; if 2/6 subjects develop DLTs, we will discontinue the study. Following completion of run---in phase I (3 or 6 subjects), we will transition to Phase 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject has recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer and has already received front line platinum based chemotherapy prior to recurrence.
- Subject has had prior secondary cytoreductive surgery yielding tumor for Lysate preparation.
- Lysate must meet release criteria.
- Subject has a current largest tumor nodule that is >1 cm CT or MRI.
- Subject is 18 years of age or older.
Key exclusion criteria (20 listed)
- Subject for whom tumor lysate does not meet release criteria.
- Subject has a positive serum Yo antibody
- Subject has a chronic or acute hepatitis C infection.
- Subject has a chronic or acute hepatitis B infection.
- Subject has positive test result at the screening visit for one or more of the following: 1. HTLV-1/2 Antibody, 2. Anti-HIV 1/2 Antibody
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/Montanide ISA 51 VGAll subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally. | Biological | Phase 1, Phase 2: Arm A, Phase 2: Arm B |
| AmpligenAll subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days. | Biological | Phase 1, Phase 2: Arm B |
| PrevnarA vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness. | Biological | Phase 1, Phase 2: Arm A, Phase 2: Arm B |
Primary outcome
Number of Participants With Adverse Events
Time frame: within 30 days of last vaccination
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 4.0). All toxicities observed within 30 days of last vaccination will be included. All patients that receive at least one vaccination will be included in the toxicity analysis.
2 secondary outcomes
Immune Response
Time frame: within 30 days of vaccination
Clinical Response
Time frame: within 30 days of vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janos Tanyi, MD, Ph.D principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OC-L/Montanide ISA 51 VG, Ampligen and Prevnar in people with 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 13 inclusion and 20 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 15 Nov 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 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?
Yes. Results are posted in the registry (first posted 15 Nov 2021). 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: within 30 days of last vaccination). 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 15 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.