AzTrials
AzTrials

Prostate CancerPhase 2NCT01706458

Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

A Phase 2 study testing sipuleucel-T and DNA Vaccine in people with Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
sipuleucel-T and DNA Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
20 May 2013to 13 Aug 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy)
  • Castrate-resistant disease, defined as follows:
  • All patients must have received standard of care androgen deprivation treatment before trial entry (surgical castration versus gonadotropin-releasing hormone [GnRH] analogue or antagonist treatment), and subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study
  • Patients may have been treated previously with a nonsteroidal antiandrogen, with evidence of disease progression subsequently; subjects must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration
  • Subjects who demonstrate an anti-androgen withdrawal response, defined as a >= 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal
Show all 23Show fewer
  • Castration levels of testosterone (< 50 ng/dL) within 2 weeks of registration
  • Progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) bone scan criteria or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during or after completing last therapy:
  • PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value >= 2.0 ng/mL
  • Measurable disease: >= 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be at least 15 mm by spiral CT to be considered a target lesion
  • Non-measurable (bone) disease: the appearance of two or more new areas of uptake on bone scan consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance imaging [MRI])
  • Must have >= 3 serum PSA values obtained over at least a 12 week period of time prior to registration, including the day of screening, to calculate a PSA doubling time; Note: PSA's are not required to be obtained at the same laboratory; use all PSA values that have been done in last 6 months to calculate PSA doubling time
  • Life expectancy of at least 6 months
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • White blood cell >= 2000/mm^3
  • Absolute neutrophil count >= 1000/mm^3
  • Hemoglobin (HgB) >= 9.0 mg/dL
  • Platelets >= 100,000/mm^3
  • Creatinine =< 2.0 mg/dL
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
  • Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, and for active hepatitis B or hepatitis C, within 14 days of first peripheral blood collection for sipuleucel-T
  • Patients must be at least 4 weeks from any prior treatments and have recovered (to < grade 2) from acute toxicity attributed to this prior treatment
  • Patients must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding

Who cannot join

  • Small cell or other variant prostate cancer histology
  • Patients may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than androgen deprivation
  • Symptomatic metastatic disease, as defined by the need for opioid analgesics for the treatment of pain attributed to a prostate cancer metastatic lesion; patients receiving opioids must receive approval from the principal investigator (PI) for eligibility
  • Patients may not have been treated with prior sipuleucel-T
  • Treatment with any of the following medications within 28 days of registration, or while on study, is prohibited:
  • Systemic corticosteroids (at doses over the equivalent of 1 mg prednisone daily); inhaled, intranasal or topical corticosteroids are acceptable
Show all 24Show fewer
  • Prostate cancer (PC)-SPES
  • Saw palmetto
  • Megestrol
  • Ketoconazole
  • 5-alpha-reductase inhibitors-patients already taking 5-alpha-reductase inhibitors prior to 28 days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while patients are on study
  • Diethyl stilbestrol
  • Abiraterone
  • Any other hormonal agent or supplement being used with the intent of cancer treatment
  • External beam radiation therapy within 4 weeks of registration is prohibited, or anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal cord compression) within 3 months of registration
  • Major surgery within 4 weeks of registration is prohibited
  • Prior cytotoxic chemotherapy (e.g. docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
  • Patients with a history of life-threatening autoimmune disease
  • Patients who have undergone splenectomy
  • Patients must not have other active malignancies other than non-melanoma skin cancers or carcinoma in situ of the bladder; subjects with a history of other cancers who have been adequately treated and have been recurrence-free for >= 3 years are eligible
  • Patients with known brain metastases
  • Any antibiotic therapy or evidence of infection within 1 week of registration
  • Any other medical intervention or condition, which, in the opinion of the PI could compromise patient safety or adherence with the study requirements
  • Patients cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

This randomized pilot clinical trial studies sipuleucel-T with or without deoxyribonucleic acid (DNA) vaccine therapy in treating patients with prostate cancer that has not responded to previous treatment with hormones and has spread to other places in the body. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine works better with or without DNA vaccine therapy in treating prostate cancer.

Conditions
Prostate Cancer
Being tested
sipuleucel-T, DNA Vaccine
Keywords
Vaccine, pTVG-HP, Prostate Cancer, Castrate Resistant
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sipuleucel-TBiological

    Also called Provenge

    Given IV

  • DNA VaccineBiological

    Also called pTVG-HP with rhGM-CSF

    Given ID

Study groups in NCT01706458
Study groupRoleWhat they receive
sipuleucel-TActive comparatorPatients receive sipuleucel-T IV on weeks 0, 2, and 4.
Receives: Biological: sipuleucel-T
sipuleucel-T with DNA VaccineExperimentalPatients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.
Receives: Biological: sipuleucel-T; Biological: DNA Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Immune Response Following Treatment

    The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.

    Measured: 12 months

Secondary outcomes (3)

  1. Progression-free Survival

    Percentage of patients without radiographic progression at 12 months.

    Measured: 12 months

  2. Time to Radiographic Disease Progression

    Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.

    Measured: 12 months

  3. Measure Prostate-specific Antigen (PSA) Doubling Time

    PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time "response".

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study start20 May 2013
  3. Primary completion12 Jun 2017
  4. Study completion13 Aug 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706458
Sponsor's protocol ID
CO11816
Other IDs
A534260, SMPH/MEDICINE/MEDICINE*H, NCI-2012-02026, 2012-0352
Status last verified
May 2021
First submitted
9 Oct 2012
Last updated
18 Jun 2021
Data monitoring committee
Yes

Publications

  • Wargowski E, Johnson LE, Eickhoff JC, Delmastro L, Staab MJ, Liu G, McNeel DG. Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine. J Immunother Cancer. 2018 Mar 13;6(1):21. doi: 10.1186/s40425-018-0333-y.

    PubMed 29534736

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sipuleucel-T and DNA Vaccine in people with Prostate Cancer, run by University of Wisconsin, Madison 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 23 inclusion and 24 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 18 Jun 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Immune Response Following Treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706458, which also lists 1 linked publication.

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 18 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in