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Hormone Refractory Prostate CancerPhase 2NCT01194960

TroVax® In Subjects With Hormone Refractory Prostate Cancer (HRPC)

A Phase 2 study testing Docetaxel and TroVax in people with Hormone Refractory Prostate Cancer, run by Oxford BioMedica at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
Docetaxel and TroVax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
7 sitesUnited States
Study dates
Aug 2010to Mar 2013
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed \& dated written informed consent obtained from subject in accordance w/local regulations.
  • Histologically confirmed conventional and/or mucinous adenocarcinoma of the prostate. If histological confirmation is not available, cytological confirmation will be permitted in lieu.
  • Must meet one of following 3 criteria for progressive disease following androgen deprivation:
  • Subjects w/nodal or visceral metastases:
  • Must have progressive disease defined by RECIST criteria or defined by the Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008).
  • Subjects w/no measurable disease:
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  • PSA only disease must have an elevated PSA as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). PSA must indicate progressive disease defined as rising PSA values, at least 7 days apart, >2 ng/mL in the 28 days prior to randomization.
  • Subjects w/bone involvement:
  • New disease on bone scan as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). 4. Subjects on stable dose of bisphosphonates showing subsequent tumor progression may continue on this medication; however, subjects are not allowed to initiate bisphosphonate therapy w/in 28 days prior to starting study treatment at Week 1 or at any time after that during the study, 5. Must be clinically immunocompetent. Clinical immunocompetence assumed unless subject has been diagnosed as immunosuppressed, is receiving immunosuppressive chemotherapy for oncology disorders, or is receiving immunosuppressive therapy following transplant, in which case they will be excluded.
  • 6. Subject free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, \& Rheumatoid Arthritis).
  • 7. Subject has adequate bone marrow function defined by Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.
  • 8. Subject has peripheral neuropathy grade ≤1. 9. Subject has ECOG status of 0 or 1. 10. Minimum life expectancy ≥6 months. 11. Progressive disease (as defined above) must be documented after discontinuation of the hormonal and anti-androgen therapy.
  • 12. Subject continues to stay on medical treatment such as LHRH agonists or LHRH antagonists to maintain testosterone value of <50ng/dL.

Who cannot join

  • Subject has received prior chemotherapy for prostate cancer at any time. Subject has received chemotherapy for any other reason within five years of screening.
  • Subject is receiving any other hormonal therapy, including any dose of Megestrol Acetate, Finasteride, any herbal product known to decrease PSA levels (e.g., Saw Palmetto \& PC-SPES), or any systemic corticosteroid must discontinue agent for at least 4 weeks prior to the anticipated Week 1 visit. LHRH agonists or LHRH antagonists do not need to be discontinued.
  • Subject has started bisphosphonate or denosumab therapy less than 28 days before the anticipated Week 1 visit.
  • Subject is using supplements or complementary medicines/botanicals. Subjects should review label w/their doctor prior to enrolment. Exceptions to this exclusion:
  • Conventional multivitamin supplements
  • Selenium
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  • Lycopene
  • Soy supplements
  • Vitamin E
  • Fish oil supplements
  • Vitamin D
  • Glucosamine supplements
  • Age-related eye disease vitamins
  • Ginkgo biloba
  • Subject has had major surgery or radiation therapy completed <4 weeks prior to screening.
  • Corticosteroids are not permitted except for (a) nasal sprays and inhalers, (b) orally prescribed as replacement therapy in the case of adrenal insufficiency, (c) oral or IV dexamethasone administration used acutely in combination with docetaxel, (d) parenteral use on a single occasion, (e) low dose parenteral use for a maximum of 5 days and (f) acute and sporadic parenteral use for acute asthma.
  • Subject is known to test positive for HIV or hepatitis B or C.
  • Subject receiving concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents.
  • Subject has Platelet count >400,000/μL; Monocytes >80,000/μL; Haemoglobin <11g/dL.
  • Subject has cerebral metastases (known from previous investigations or clinically detectable).
  • Subject has serum testosterone >50ng/dL.
  • Subject has rheumatoid disease (asymptomatic subjects w/controlled \& rarely flaring rheumatoid arthritis are also excluded).
  • Subject exhibits evidence of symptomatic congestive heart failure, pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction or active ischemia on ECG. If an ECG taken prior to screening but within 28 days of the anticipated Week 1 visit is not available, an ECG must be performed at screening.
  • Subject has uncontrolled severe hypertension >150/100mm Hg (if controlled w/medication this is not an exclusion).
  • Subject is hypotensive.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • New York University Cancer Institute

    New York, New York, 10016

  • GU Research Network

    Omaha, Nebraska, 68130

  • San Bernardino Urology

    San Bernardino, California, 92404

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Randomized Phase II Study to Assess the Activity of TroVax® (MVA-5T4) Plus Docetaxel Versus Docetaxel Alone in Subjects With Progressive Hormone Refractory Prostate Cancer

Based on both pre-clinical and clinical data, it may be advantageous to administer a cancer vaccine before chemotherapy to enhance immune responses, thus leading to a more effective therapeutic approach for subjects with metastatic HRPC. This clinical study will evaluate the role of combination therapy of TroVax® plus Docetaxel vs. Docetaxel alone on the progression free survival (PFS) of subjects with HRPC.

Being tested
Docetaxel, TroVax
Keywords
cancer of prostate, cancer of the prostate, neoplasms prostate, neoplasms prostatic, prostate cancer, prostate neoplasms, prostatic cancer, prostate specific antigen, prostatic hyperplasia
Medical subject headings
Prostatic Neoplasms, Prostatic Hyperplasia

What participants receive

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

  • DocetaxelDrug

    Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.

  • TroVaxDrug

    Trovax on Days 1,10, 22 and then Weeks 7, 10, 13, 19, 25, 31 and 37

Study groups in NCT01194960
Study groupRoleWhat they receive
Docetaxel AloneActive comparatorSubjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
Receives: Drug: Docetaxel
TroVax plus DocetaxelExperimentalSubjects will receive both TroVax plus 10 cycles of Docetaxel.
Receives: Drug: Docetaxel; Drug: TroVax

What is being measured

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

  1. Progression-free survival

    To establish whether the incidence of progression-free survival (as defined by the absence of progression assessed by both RECIST and PCWG2 criteria) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.

    Measured: Week 37

Secondary outcomes (1)

  1. Clinical progression-free survival

    To establish whether the incidence of clinical progression-free survival (defined by the absence of progression assessed by RECIST criteria alone) at week 37 in the TroVax® plus Docetaxel treatment arm is higher than the incidence in the Docetaxel alone treatment arm.

    Measured: 37 weeks

Timeline

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

  1. First posted3 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194960
Sponsor's protocol ID
TV2/001/09
Status last verified
Oct 2020
First submitted
2 Sep 2010
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Harrop R, Chu F, Gabrail N, Srinivas S, Blount D, Ferrari A. Vaccination of castration-resistant prostate cancer patients with TroVax (MVA-5T4) in combination with docetaxel: a randomized phase II trial. Cancer Immunol Immunother. 2013 Sep;62(9):1511-20. doi: 10.1007/s00262-013-1457-z. Epub 2013 Jul 23.

    PubMed 23877659

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and TroVax in people with Hormone Refractory Prostate Cancer, run by Oxford BioMedica at 7 sites 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 13 inclusion and 25 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: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The study was stopped early. Results are not available in the source record.

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?

Progression-free survival (time frame: Week 37). 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 NCT01194960, 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 19 Oct 2020.

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