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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer

This trial does not test a peptide that PepBank tracks.

  • Names Goserelin, does not test it. It appears in the summary.
  • Names Leuprolide, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
Roswell Park Cancer Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2009
Primary completion
5 Oct 2018
Completion
5 Oct 2019
First posted
2 Sept 2009 (estimated)
Last update posted
3 Nov 2020
Conditions
Cancer of Prostate · Cancer of the Prostate · Neoplasms, Prostate · Neoplasms, Prostatic · Prostate Cancer · Prostate Neoplasms · Prostatic Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020122014201620182020
  1. Ph 2

    Dendritic Cell (DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With Prostate Cancer

    NCT00970203

    Sept 2009 to 5 Oct 2019

Registry summary

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.).

Interventions

  • androgen ablation (AA)Biological
  • DC1 vaccineBiological

Arms2

  • 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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine

    Time frame · 16 weeks

    Registry description

    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).

  2. Tolerability and Toxicity of the Alpha-DC1 Vaccine

    Time frame · 16 weeks

    Registry description

    The percentage of patients who experienced vaccine related toxicity.

  3. The Effect of the DC1 Vaccine on Time to PSA Progression Compared to AA Alone

    Time frame · Approximately 18 months

    Registry description

    The mean difference between time to relapse on androgen ablation plus alpha DC-1 vaccine vs androgen ablation

Secondary outcomes(5)
  1. Change in PSA Velocity Prior to and Following the Proposed Treatment.

    Time frame · Approximately 18 months

  2. 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

  3. Evaluate the Vaccination-induced Changes of Th1/Th2 Profiles of the Responses to PAP and PSMA

    Time frame · Approximately 18 to 24 months

  4. 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

  5. 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 16 weeks

Percentage of Patients to Successfully Generate and Administer the Alpha-DC1 Vaccine

GroupValue (percentage of participants)
Cohort A100
Cohort B100
Primary outcomeNumber· 16 weeks

Tolerability and Toxicity of the Alpha-DC1 Vaccine

GroupValue (percentage of participants)
Cohort A0
Cohort B0
Primary outcome· Approximately 18 months

The Effect of the DC1 Vaccine on Time to PSA Progression Compared to AA Alone

GroupValue
Cohort Anot posted
Cohort Bnot posted
Secondary and other outcome results(5)
Secondary outcome· Approximately 18 months

Change in PSA Velocity Prior to and Following the Proposed Treatment.

GroupValue
Cohort Anot posted
Cohort Bnot posted
Secondary outcome· Approximately 17 weeks

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)

GroupValue
Cohort Anot posted
Cohort Bnot posted
Secondary outcome· Approximately 18 to 24 months

Evaluate the Vaccination-induced Changes of Th1/Th2 Profiles of the Responses to PAP and PSMA

GroupValue
Cohort Anot posted
Cohort Bnot posted
Secondary outcome· 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

GroupValue
Cohort Anot posted
Cohort Bnot posted
Secondary outcome· 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

GroupValue
Cohort Anot posted
Cohort Bnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 total0 / 70 / 77 / 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 total0 / 60 / 66 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Eligibility Criteria * Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesicle involvement, provided all visible disease was surgically removed) who have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy, as defined below. * Age 18 years or older * Histologically confirmed diagnosis of prostate cancer. * Previous treatment with definitive surgery or radiation therapy or both. * No evidence of metastatic disease on physical exam, CT/MRI/CXR (see Section 7.1 for radiologic imaging), and bone scan within 4 weeks prior to randomization. * Prior neoadjuvant/adjuvant hormonal, androgen deprivation therapy, or chemotherapy is allowed if it was last used \> 12 months prior to first vaccination. * No therapy modulating testosterone levels (such as leuteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 12 months prior to first vaccination. Agents such as 5α-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids (replacement doses of steroids are allowed), PC-SPES, and Saw Palmetto are not permitted at any time during the period that the PSA values are being collected. * Hormone-sensitive prostate cancer as evident by a serum total testosterone level \> 150 ng/dL or \> 6 nmol/L at the time of enrollment within 4 weeks prior to randomization. * All patients must have evidence of biochemical progression as determined by a reference PSA value followed by 1 confirmatory rising PSA value, higher than the previous value, obtained at least 2 weeks apart. All of these PSA values must be obtained at the same reference lab, and all must be done within 6 months prior to enrollment. * The most recent of the PSA values must be ≥ 2.0 ng/mL. This measurement must be obtained within 1 month prior to enrollment. * The PSA doubling time (PSA-DT) must be less than 12 months. * ECOG performance status 0 or 1. * Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count \> 1,500/µL * Platelets \> 100,000/µL * Total bilirubin 1.5 x upper limit of normal (ULN) * SGOT (AST) and SGPT (ALT) \< 2.5 x institutional ULN * Creatinine 1.5 x ULN * The effects of dendritic cell vaccines on the developing human fetus are unknown. For this reason men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Exclusion Criteria * Patients must not be receiving other investigational agents or concurrent anticancer therapy. * No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients must not have active eczema, atopic dermatitis, or other exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis, herpes or other open rashes or wounds). * Presence of an active acute or chronic infection, including urinary tract infection, HIV or viral hepatitis. HIV patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections. If clinically indicate, HIV/viral hepatitis testing will be performed to confirm status. * Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients receiving replacement thyroid hormone would be eligible. * No concurrent use of systemic steroids, except for local (topical, nasal, or inhaled) steroid use. Adrenal replacement doses of corticosteroids are allowed. * Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and superficial bladder cancer or malignancy within last 3 years).

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