Adenocarcinoma of the ProstatePhase 1DRibbleNCT02234921
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
A Phase 1 study testing Cyclophosphamide, DRibble Vaccine and HPV Vaccinations in people with Adenocarcinoma of the Prostate, run by UbiVac at 1 site in United States.
Trial summary
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate
- What is being tested?
- Cyclophosphamide, DRibble Vaccine and HPV Vaccinations
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2014to 15 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Health & Services
Portland, Oregon, 97213
About this study
Official title: A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
Read the 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.
- Conditions
- Adenocarcinoma of the Prostate
- Being tested
- Cyclophosphamide, DRibble Vaccine, HPV Vaccinations, Imiquimod
- Keywords
- Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome
- Medical subject headings
- Adenocarcinoma, Neoplasm Metastasis, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan
A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
DRibble VaccineBiological
Also called DPV-001 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.
HPV VaccinationsBiological
Also called Ceravix
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.
ImiquimodDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DRibble Vaccine | Experimental | 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). Receives: Drug: Cyclophosphamide; Biological: DRibble Vaccine; Biological: HPV Vaccinations; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
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.
Measured: 28 Weeks
Secondary outcomes (2)
Immune Response
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.
Measured: 28 weeks
Prostate Cancer Response to DRibble vaccine
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.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start24 Oct 2014
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- UbiVac
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Providence Health & Services, Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234921
- Sponsor's protocol ID
- 14-116B
- Acronym
- DRibble
- Status last verified
- Oct 2018
- First submitted
- 4 Sep 2014
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT02234921
- Acronym / sponsor ID
- DRibble / 14-116B
- Conditions
- Adenocarcinoma of the Prostate
- Keywords
- Prostate, Adenocarcinoma, Metastatic, DRibble, Immunotherapy, Microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UbiVacIndustry (pharma, biotech, devices)
- Collaborators
- Providence Health & Services, Providence Cancer Center, Providence Cancer Center, Earle A. Chiles Research Institute
- Study start
- 24 Oct 2014 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DRibble Vaccine | Experimental | Drug: Cyclophosphamide, Biological: DRibble Vaccine, Biological: HPV Vaccinations, Drug: ImiquimodPatients 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). |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: CytoxanA single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine. | Drug | DRibble Vaccine |
| DRibble VaccineAlso: DPV-001 DRibble vaccineDRibble 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. | Biological | DRibble Vaccine |
| HPV VaccinationsAlso: CeravixPatients 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. | Biological | DRibble Vaccine |
| ImiquimodImiquimod 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. | Drug | DRibble Vaccine |
Primary outcome
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.
2 secondary outcomes
Immune Response
Time frame: 28 weeks
Prostate Cancer Response to DRibble vaccine
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Curti, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide, DRibble Vaccine and HPV Vaccinations in people with Adenocarcinoma of the Prostate, run by UbiVac at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: 28 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.