Trial Outcomes & Findings for Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod (NCT NCT00799110)
NCT ID: NCT00799110
Last Updated: 2026-08-05
Results Overview
To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.
TERMINATED
PHASE2
15 participants
2 years
2026-08-05
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccination Plus GM-CSF
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
|
Group 2: Vaccine, GM-CSF and Imiquimod,
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
imiquimod: Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
Baseline characteristics by cohort
| Measure |
Group 1
n=15 Participants
Vaccination plus GM-CSF
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
|
Group 2
Vaccine, GM-CSF and imiquimod,
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
imiquimod: Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Age, Continuous
|
58 years
n=20 Participants
|
—
|
58 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=20 Participants
|
—
|
15 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Due to early termination, this endpoint was not able to be analyzed. No patients were treated with imiquimod so no comparative analysis could be performed. Tests were slated to be performed at completion of the study. As the study was terminated due to withdrawal of funding, the analysis could not be performed because the funding to perform the laboratory testing was withdrawn prior to the analysis being completed. This will not be analyzed in the future.
To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsToxicity associated with vaccination with DC/tumor fusion when given with GM-CSF.
Outcome measures
| Measure |
Group 1
n=15 Participants
Vaccination plus GM-CSF
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
|
Group 2: Vaccine, GM-CSF and Imiquimod,
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
imiquimod: Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
|
|---|---|---|
|
Toxicity Associated With Vaccination
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Participants who achieved at least a Partial Response (PR) to first line therapy were evaluated for duration of response through 2 years post vaccination.
Clinical response to vaccination with DC/tumor fusion when given with GM-CSF.
Outcome measures
| Measure |
Group 1
n=15 Participants
Vaccination plus GM-CSF
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
|
Group 2: Vaccine, GM-CSF and Imiquimod,
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
imiquimod: Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
|
|---|---|---|
|
Clinical Response to Vaccination
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Due to early termination, this endpoint was not able to be analyzed. No patients were treated with imiquimod so no comparative analysis could be performed. Tests were slated to be performed at completion of the study. As the study was terminated due to withdrawal of funding, the analysis could not be performed because the funding to perform the laboratory testing was withdrawn prior to the analysis being completed. This will not be analyzed in the future.
Immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.
Outcome measures
Outcome data not reported
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=15 participants at risk
Vaccination plus GM-CSF
GM-CSF: Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Dendritic Cell/Tumor Fusion Vaccine: Given subcutaneously once every three weeks for a total of three vaccines
|
|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
80.0%
12/15 • Number of events 28 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
|
General disorders
Headache
|
13.3%
2/15 • Number of events 3 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
5/15 • Number of events 5 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
|
Investigations
Positive ANA Titer
|
13.3%
2/15 • Number of events 2 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Number of events 4 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
|
Blood and lymphatic system disorders
Edema, limb
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the first vaccine through six months following the last vaccine, up to 1 year.
|
Additional Information
Emma Logan, Research Nursing Director
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place