Prostatic NeoplasmsPhase 2NCT00521274
Study of Trovax® Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer
A Phase 2 study testing MVA 5T4 and Docetaxel in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the role of combination therapy with Trovax plus Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific antigen (PSA). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- MVA 5T4 and Docetaxel
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2008
- 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
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive disease after androgen deprivation.
- ECOG Status < 2.
- No prior chemotherapy for prostate cancer therapy
- At least four weeks have lapsed since prior chemotherapy (if administered)
- Patients on stable doses of bisphosphonates that show subsequent tumor progression may continue on this medication; however, patients are not allowed to initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
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- Clinically immunocompetent.
- Free of clinically apparent/active autoimmune disease
- Absolute Lymphocyte Count ≥ 500/µl, ANC >1200/µl, Platelet count >100,000/µl, Hemoglobin > 10 mg/dl, Peripheral neuropathy <1.
- No evidence of active ischemia on ECG
- Age greater 18 years
Who cannot join
- Patients who have received prior chemotherapy.
- Patients receiving any other hormonal therapy, including any dose of megestrolacetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy.
- Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
- No supplements or complementary medicines/botanicals are permitted during the study, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements, Vitamin E
- Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment
- Major surgery or radiation therapy completed < 4 weeks prior to enrollment.
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- Prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
- "Currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy more than 5 years previously and have no known evidence of residual or recurrent disease
- Serious intercurrent infections or nonmalignant medical illnesses which are uncontrolled.
- Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
- AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. The bilirubin must be within normal limits.
- Renal function creatinine ≥1.5 x ULN.
- Known allergy to egg proteins.
- Known allergy to neomycin.
- History of allergic response to previous vaccinia vaccinations.
- Chronic oral corticosteroid use (especially anti-emetics) unless prescribed as replacement therapy in the case of adrenal insufficiency.
- Known to test positive for HIV or hepatitis B or C - testing prior to study not required.
- Clinical indication of reduced cardiac function or an ejection fraction of ≤ 40%.
- Requirement for radiotherapy (this is a sign of disease progression and is classed as a withdrawal criterion).
- Concurrent chemotherapy, immunotherapy and radiation therapy
- No investigational or commercial agents or therapies other than those included in protocol treatment may be administered with the intent to treat the patient's malignancy.
- Prior exposure to TroVax®.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: A Phase II Trial to Assess the Activity of MVA 5T4 (Trovax®) Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer (HRPC)
The purpose of this study is to evaluate the role of combination therapy with Trovax plus Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific antigen (PSA).
Read the detailed description
Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer.
Trovax is vaccine that targets 5T4 receptors on tumor cells. 5T4 has been detected in the majority of primary prostate cancers. Based on 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 therapeutic approach for patients with metastatic androgen independent prostate cancer (AIPC).
- Conditions
- Prostatic Neoplasms
- Being tested
- MVA 5T4, Docetaxel
- Keywords
- Progressive Hormone Refractory Prostate Cancer, HRPC, MVA 5T4, Trovax®, Docetaxel, M3thodist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA 5T4Biological
Also called TroVax
Docetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration.
DocetaxelDrug
Also called Taxotere
Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients randomized to Arm 1 will receive treatment cycles of Docetaxel and vaccine.
PI relocated, data not available. Receives: Biological: MVA 5T4 |
| 2 | Active comparator | Patients randomized to Arm 2 will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over).
PI relocated, data not available. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to PSA progression Safety: To compare adverse events, laboratory measurements and vital sign measurements between the treatment groups
Measured: PSA measured every 6 weeks
Secondary outcomes (1)
PSA response rate Tumor response Overall survival
Measured: PSA and tumor response measured every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionAug 2008
Why it stopped: Oxford BioMedica halted TroVax injections
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford BioMedica
- Responsible party
- Sponsor
- Investigators
- Robert J Amato, DO, Principal investigator, Baylor College of Medicine - Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521274
- Sponsor's protocol ID
- HMRI IRB#0407-0036
- Other IDs
- PCa-07-101
- Status last verified
- Mar 2016
- First submitted
- 23 Aug 2007
- Last updated
- 17 Mar 2016
- 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 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess the Activity of MVA 5T4 (Trovax®) Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00521274
- Acronym / sponsor ID
- HMRI IRB#0407-0036
- Conditions
- Prostatic Neoplasms
- Keywords
- Progressive Hormone Refractory Prostate Cancer, HRPC, MVA 5T4, Trovax®, Docetaxel, M3thodist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Oxford BioMedica halted TroVax injections
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Oxford BioMedica
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Aug 2007 (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.
The purpose of this study is to evaluate the role of combination therapy with Trovax plus Docetaxel or Docetaxel alone in patients with prostate cancer with a rising prostate specific antigen (PSA).
Detailed description
Docetaxel is the most active chemotherapeutic agent in the treatment of prostate cancer.
Trovax is vaccine that targets 5T4 receptors on tumor cells. 5T4 has been detected in the majority of primary prostate cancers. Based on 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 therapeutic approach for patients with metastatic androgen independent prostate cancer (AIPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MVA 5T4Patients randomized to Arm 1 will receive treatment cycles of Docetaxel and vaccine. PI relocated, data not available. |
| 2 | Active comparator | Drug: DocetaxelPatients randomized to Arm 2 will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). PI relocated, data not available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive disease after androgen deprivation.
- ECOG Status < 2.
- No prior chemotherapy for prostate cancer therapy
- At least four weeks have lapsed since prior chemotherapy (if administered)
Key exclusion criteria (22 listed)
- Patients who have received prior chemotherapy.
- Patients receiving any other hormonal therapy, including any dose of megestrolacetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES), or any systemic corticosteroid must discontinue the agent for at least 4 weeks prior to enrollment. Progressive disease (as defined above) must be documented after discontinuation of the hormonal therapy.
- Patients that initiate bisphosphonate therapy within one month prior to starting therapy or throughout the study.
- No supplements or complementary medicines/botanicals are permitted during the study, except for any combination of the following: conventional multivitamin supplements, selenium, lycopene, soy supplements, Vitamin E
- Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment
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 |
|---|---|---|
| MVA 5T4Also: TroVaxDocetaxel will be administered at the completion of the first three TroVax® injections. Patients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients will receive up to 10 total Docetaxel infusions over the course of the study. Subsequent TroVax® injections will be delivered on Day 1 of each Docetaxel cycle, 2 hours prior to the chemotherapy administration. | Biological | 1 |
| DocetaxelAlso: TaxoterePatients will receive Docetaxel 75 mg/m2 on Day 1 of each cycle (1 cycle = 3 weeks). Patients who demonstrate disease progression will continue with their chemo as scheduled in Arm 2 but will also begin to receive TroVax® (cross-over). Patients will receive up to 10 total Docetaxel infusions over the course of the study. If patients cross-over, TroVax® will be administered 2 hours prior to the chemotherapy administration. | Drug | 2 |
Primary outcome
Time to PSA progression Safety: To compare adverse events, laboratory measurements and vital sign measurements between the treatment groups
Time frame: PSA measured every 6 weeks
1 secondary outcome
PSA response rate Tumor response Overall survival
Time frame: PSA and tumor response measured every 6 weeks
Results and safety
The study was stopped early (reason given: Oxford BioMedica halted TroVax injections). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- 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.
Robert J Amato, DO principal investigator
Baylor College of Medicine - Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA 5T4 and Docetaxel in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute 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 11 inclusion and 22 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 17 Mar 2016. 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?
The study was stopped early (reason given: Oxford BioMedica halted TroVax injections). 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?
Time to PSA progression Safety: To compare adverse events, laboratory measurements and vital sign measurements between the treatment groups (time frame: PSA measured every 6 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 17 Mar 2016.