Trial Outcomes & Findings for Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer (NCT NCT00753220)

Results Overview

PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer. ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2014-11-04

Participant Flow

Men at least 18 years of age diagnosed with prostate cancer with metastases limited to three sites (e.g., lymph nodes and/or bone) who have been determined to have undergone progression of their cancer under androgen blockade (i.e., are androgen-independent) will be eligible for this study.

Prior to any screening evaluations, the purpose of the study \& study related tests/procedures will be explained, then subject signs ICF. Subject will undergo screening assessments to determine if he meets all of the inclusion criteria \& none of the exclusion criteria. Screen failures will not be eligible for re-screening.

Participant milestones

Participant milestones
Measure	VDC2008 Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8
Overall Study STARTED	7
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Autologous Dendritic Cells Injected Into the Prostate After Cryoablation for Advanced Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VDC2008 n=7 Participants Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	72 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

PROTOCOL EXCERPT: The primary objective of the Phase I Portion of this study is the determination of the maximum tolerated dose (MTD) of intratumorally injected study agent VDC2008 administered following cryoablation of the prostate, and pre- and post-treatment with a low-dose cyclophosphamide therapy, as determined by toxicity and adverse event monitoring following treatment of metastatic androgen-independent prostate cancer. ADDITIONAL INFORMATION: MTD was not reached by any study participant prior to end of the study. Additional participants would have been necessary to determine MTD.

Outcome measures

Outcome measures
Measure	VDC2008 n=7 Participants Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8
Maximum Tolerated Dose (MTD)	NA intratumorally delivered cells MTD was not reached by any study participant prior to end of the study.

Adverse Events

VDC2008

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VDC2008 n=7 participants at risk Cryoablation of prostate followed by dendritic cell injection into prostate and low dose cyclophosphamide therapy VDC2008 : Intratumoral injection of VDC2008 post-cryotherapy. Dosage will depend on cohort: 2.5 x 10\^7, 7.5 x 10\^7 or 1.0 x 10\^8
Nervous system disorders Memory	14.3% 1/7 • Number of events 1 • Overall Study (1 year, 2 months)
Gastrointestinal disorders Heartburn	14.3% 1/7 • Number of events 1 • Overall Study (1 year, 2 months)
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Overall Study (1 year, 2 months)
General disorders Pain	14.3% 1/7 • Number of events 1 • Overall Study (1 year, 2 months)
Metabolism and nutrition disorders Loss of Appetite	14.3% 1/7 • Number of events 1 • Overall Study (1 year, 2 months)

Additional Information

Dr. Duke K. Bahn

Prostate Institute of America

Phone: 888-234-0004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place