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Trial record 91 of 91 for:    cervarix

Pilot Study of DRibble Vaccine for Prostate Cancer Patients (DRibble)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234921
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Providence Health & Services
Providence Cancer Center
Providence Cancer Center, Earle A. Chiles Research Institute
Information provided by (Responsible Party):
UbiVac

Brief Summary:
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Drug: Cyclophosphamide Biological: DRibble Vaccine Biological: HPV Vaccinations Drug: Imiquimod Phase 1

Detailed Description:

The primary objective of this pilot study is to assess the safety and tolerability of DRibble vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.

This study will also assess:

  • the immune profile of tumor biopsy specimens if sites amenable to biopsy are present
  • humoral and cellular responses to cancer antigens after DRibble vaccination
  • the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination

An exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
Actual Study Start Date : October 24, 2014
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Imiquimod

Arm Intervention/treatment
Experimental: DRibble Vaccine
Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
Drug: Cyclophosphamide
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
Other Name: Cytoxan

Biological: DRibble Vaccine
DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.
Other Name: DPV-001 DRibble vaccine

Biological: HPV Vaccinations
Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.
Other Name: Ceravix

Drug: Imiquimod
Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.




Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: 28 Weeks ]
    Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.


Secondary Outcome Measures :
  1. Immune Response [ Time Frame: 28 weeks ]
    Patients will have 11 blood draws during the study to evaluate the immune response. In addition, patients will undergo two leukapheresis procedures and provide two biopsy samples (if cancer is amenable to safe biopsy) to evaluate immune response.

  2. Prostate Cancer Response to DRibble vaccine [ Time Frame: 28 weeks ]
    Patients will have 8 Prostate-Specific Antigen (PSA) Tests over a 22-week period and 3 CT scans over a 28-week period to assess response to treatment.


Other Outcome Measures:
  1. Microbiome identification [ Time Frame: 12 weeks ]
    Patients will provide 3 stool samples for microbiome identification for future research to see if there is a correlation with response to treatment.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. Either histologic or serum marker diagnosis is acceptable.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Ability to give informed consent and comply with the protocol.
  • Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
  • Patients must have normal organ and marrow function as determined by routine blood tests

Exclusion Criteria:

  • Active autoimmune disease except vitiligo or hypothyroidism.
  • Active other malignancy.
  • Known HIV positive and/or Hepatitis B or C positive.
  • Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234921


Locations
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United States, Oregon
Providence Health & Services
Portland, Oregon, United States, 97213
Sponsors and Collaborators
UbiVac
Providence Health & Services
Providence Cancer Center
Providence Cancer Center, Earle A. Chiles Research Institute
Investigators
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Principal Investigator: Brendan Curti, MD Providence Health & Services

Additional Information:
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Responsible Party: UbiVac
ClinicalTrials.gov Identifier: NCT02234921     History of Changes
Other Study ID Numbers: 14-116B
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by UbiVac:
Prostate
Adenocarcinoma
Metastatic
DRibble
Immunotherapy
Microbiome

Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vaccines
Cyclophosphamide
Imiquimod
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Adjuvants, Immunologic
Interferon Inducers