Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Vaccines

Patients receive sipuleucel-T IV on weeks 0, 2, and 4.

Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.

sipuleucel-T

DNA Vaccine

Douglas McNeel, M.D., PhD

This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in treating prostate cancer.

Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.

A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency\> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.

Not performed because no progression free survival at one year.

The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.

Percentage of patients without radiographic progression at 12 months.

Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.

PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time "response".

Dendreon

University of Wisconsin, Madison

Patients receive sipuleucel-T IV on weeks 0, 2, and 4.

sipuleucel-T: Given IV

Sipuleucel-T

Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.

sipuleucel-T: Given IV

DNA Vaccine: Given ID

Sipuleucel-T With DNA Vaccine

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The ECOG Performance Status describes a patient's level of function:

0. is fully active, performance without restriction,

1. is restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work,
2. is ambulatory and capable of selfcare but unable to carry out work activities, up and about more that 50% of waking hours,
3. is capable of limited selfcare; confined to bed or chair more than 50% of waking hours,
4. is completely disabled; no selfcare, confined to bed or chair,
5. is deceased

ECOG Performance Status

>/= 9

Unknown

The Gleason Score is a grading system for prostate cancer severity. It is defined on a scale of 1-5 where 1 is low-grade tumor cells and 5 is high-grade tumor cells.

Pathologists assign two Gleason grades to a biopsy; one for the predominant pattern and another for the second most predominant pattern. The two grades are added together to determine the Gleason Score (ultimately a number between 2 and 10). Scores of 2-4 tend to indicate less aggressive cancers, and 7-10 indicate more aggressive cancers.

Gleason score

Visceral

Bone

Distant lymph nodes

Metastatic sites

Baseline PSA (ng/mL)

Baseline PSA doubling time (months)

Male patients, histological diagnosis of prostate adenocarcinoma and PSA recurrence following castration were eligible, provided they had evidence of metastatic disease by CT of abdomen/pelvis or bone scintigraphy. Progressive disease following last treatment required, per Prostate Cancer Working Group 2 criteria. 4 weeks from prior treatment.

Mary Jane Staab - Program Manager

Number of Participants With Immune Response Following Treatment

Progression-free Survival

Time to Radiographic Disease Progression

Measure Prostate-specific Antigen (PSA) Doubling Time

Overall Survival: Median Time to Death From Any Cause

This outcome measure was not determined because there was no progression free survival at one-year.

Number of Circulating Tumor Cells

Interferon Gamma Response

Granzyme B

Antibody Response

PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine

Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.

This outcome measure was not determined because there was no progression-free survival at one-year.

Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.

The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.

Spots Global Cancer Trial Database for Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial