Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.
Detailed description
See Brief Summary.
Interventions
BIOLOGICALautologous dendritic cell vaccine (DC/PC3)
ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity
Sponsors
Memorial Sloan Kettering Cancer Center
Rockefeller University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Prostate cancer Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1) \-
Exclusion criteria
central nervous system metastasis History of autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | through week 29 | adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | pre and post treatment | The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts). |
| Clinical Response | Post treatment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DC/PC3 Vaccine 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)
autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to access line for sample | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | DC/PC3 Vaccine |
|---|---|
| Age, Continuous | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
Toxicity
adverse events
Time frame: through week 29
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DC/PC3 Vaccine | Toxicity | Serious Adverse Events | 2 events |
| DC/PC3 Vaccine | Toxicity | Other Adverse Events | 204 events |
Secondary
Clinical Response
Time frame: Post treatment
Population: This data was not collected due to differences in immunogenicity based on different dendritic cell preparations. This data was no longer relevant.
Secondary
Immunogenicity
The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).
Time frame: pre and post treatment
Population: One other participant in DC/PC3 vaccine-Selected group not analyzed due to failed controls in assay.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DC/PC3 Vaccine | Immunogenicity | 62 counts per minute |
| DC/PC3- Adherent | Immunogenicity | 9461 counts per minute |