Trial Outcomes & Findings for A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT01312389)
NCT ID: NCT01312389
Last Updated: 2021-11-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
within 30 days of last vaccination
Results posted on
2021-11-15
Participant Flow
Phase 1 patients were not to continue into Phase 2. If the study had continued, new patients would have been recruited into Phase 2.
Participant milestones
| Measure |
Phase 1
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.
|
Phase 2, Arm A
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
Phase 2, Arm B
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
|---|---|---|---|
|
Phase 1
STARTED
|
3
|
0
|
0
|
|
Phase 1
COMPLETED
|
3
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial of Autologous Oxidized Tumor Cell Lysate Vaccine For Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1
n=3 Participants
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.
|
Phase 2, Arm A
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
Phase 2, Arm B
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: within 30 days of last vaccinationPopulation: The study was terminated after the first 3 patients were enrolled in Phase 1
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.
Outcome measures
| Measure |
Phase 1
n=3 Participants
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.
|
Phase 2, Arm A
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
Phase 2, Arm B
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: within 30 days of vaccinationPopulation: The study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data available to be reported.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: within 30 days of vaccinationPopulation: The study was terminated and the PI has left the institution. Despite all possible efforts to contact the PI/study team members, no data available to be reported.
Clinical Response will be estimated using immune related response criteria ir(RC)
Outcome measures
Outcome data not reported
Adverse Events
Phase 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2, Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2, Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1
n=3 participants at risk
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.
|
Phase 2, Arm A
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
Phase 2, Arm B
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.
OC-L/Montanide ISA 51 VG: 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.
Ampligen: 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.
Prevnar: A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
100.0%
3/3 • Number of events 60 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
|
General disorders
Flu-like symptoms
|
33.3%
1/3 • Number of events 2 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
|
Nervous system disorders
Neuropathy
|
33.3%
1/3 • Number of events 1 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
—
0/0 • 70 days
As there were no participants in Phase 2, there were no participants at risk for any Adverse Events.
|
Additional Information
Director of Clinical Trial Operations
University of Pennsylvania
Phone: 215-662-3324
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place