Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine
| Group | Value (percentage of participants) |
|---|---|
| Cohort A | 100 |
| Cohort B | 100 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer
NCT00970203Sept 2009 to 5 Oct 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will evaluate the feasibility, safety, and efficacy of intradermal vaccination of prostate cancer patients with alpha-type-1-polarized dendritic cells (DC1) loaded with apoptotic allogeneic tumor (LNCap). The study will target men with recurrent prostate cancer, who failed local therapy, have no measurable metastasis, but have a rising PSA with a doubling time of less than 10 months. The selection of this study group enables us to evaluate time to PSA progression, a highly relevant, clinical primary endpoint of efficacy in this two arm study. In order to facilitate infiltration of vaccination-induced T cells into tumor site(s) and to reduce tumor-specific tolerance, subjects will receive the vaccine in combination with limited androgen ablation (AA) with a LHRH analogue for 3 months. Subjects will be randomly assigned to one of two cohorts. In cohort A subjects will be first treated with limited AA alone for 3 months, and at the time of PSA relapse (PSA ≥ 1 ng/dL) will receive the DC vaccine in conjunction with AA. In cohort B, the sequence of treatment will be reversed. Efficacy will be estimated as the within-subject difference in time to PSA relapse following the combination treatment as compared to the AA alone, thus, each subject will serve as his own control. All subjects will commence the DC1-based vaccination 2 weeks prior to treatment with the LHRH analogue. Each subject will receive 1 intradermal (i.d.) dose of the vaccine at weeks 1, 5, 9, and 13 for a total of 4 doses. Additional courses of vaccination may be administered to subjects without evidence of disease progression every 3 months (±1 month) for up to 12 months depending on the number of doses originally produced and available after the 4 intended protocol doses. All doses of the vaccine will be administered intradermally (i.d.).
Experimental
Cohort A
3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
Experimental
Cohort B
3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells
Outcomes the sponsor listed as primary.
Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine
Time frame · 16 weeks
The percentage of patients for which the alpha-DC1 vaccine was generated and for which 4 vaccine injections were administered (1 injection every 4 weeks).
Tolerability and Toxicity of the Alpha-DC1 Vaccine
Time frame · 16 weeks
The percentage of patients who experienced vaccine related toxicity.
The Effect of the DC1 Vaccine on Time to PSA Progression Compared to AA Alone
Time frame · Approximately 18 months
The mean difference between time to relapse on androgen ablation plus alpha DC-1 vaccine vs androgen ablation
Change in PSA Velocity Prior to and Following the Proposed Treatment.
Time frame · Approximately 18 months
Evaluate (in All Subjects) the Vaccination-induced DTH Responses to LNCap, the Cell Line Vaccine, and to Compare This With Vaccination-induced Responses to Tumor-untreated Antigen (KLH)
Time frame · Approximately 17 weeks
Evaluate the Vaccination-induced Changes of Th1/Th2 Profiles of the Responses to PAP and PSMA
Time frame · Approximately 18 to 24 months
Evaluate the CTL Responses in Blood to the Whole LNCap Cells (in All Subjects) and (in All Subjects Who Are HLA-A2 Positive) the CTL Responses to HLA-A2.1 Restricted Peptides Derived From PAP and PSMA
Time frame · Approximately 18 to 24 months
Comprehensively Evaluate the CD4+ and CD8+ T Cell Responses (Fine Specificity and Th1/Th2/Treg Cytokine Profile) to the Previously-identified and Novel Immunogenic Epitopes of PAP and PSMA, Using the EPIMAX System
Time frame · Approximately 18 to 24 months
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Cohort A | 100 |
| Cohort B | 100 |
| Group | Value (percentage of participants) |
|---|---|
| Cohort A | 0 |
| Cohort B | 0 |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Value |
|---|---|
| Cohort A | not posted |
| Cohort B | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cohort A3 months of androgen ablation followed at PSA progression by 3 months of the combination of androgen ablation + DC1 vaccine AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg DC1 vaccine: 3-5 x 10e6 cells total | 0 / 7 | 0 / 7 | 7 / 7 |
| Cohort B3 months of the combination of androgen ablation + DC1 vaccine followed at PSA progression by 3 months of androgen ablation AA: Lupron 22.5 mg or Zoladex 10.8 mg DC vaccine: intradermal (id) vaccine of 3-5 x 10e6 cells androgen ablation (AA): Lupron 22.5 mg or Zoladex 10.8 mg DC1 vaccine: 3-5 x 10e6 cells total | 0 / 6 | 0 / 6 | 6 / 6 |
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