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Prostatic NeoplasmsPhase 2NCT00448409

Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer

A Phase 2 study testing TroVax and GM-CSF in people with Prostatic Neoplasms, run by The Methodist Hospital Research Institute 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
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Trial summary

To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer. 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?
TroVax and GM-CSF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
May 2006to May 2007
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.
  • Stable or progressive disease after androgen deprivation.
  • Karnofsky Performance Status ≥ 60%.
  • At least one prior taxane based chemotherapy for prostate cancer therapy (or patient refusal of chemotherapy)
  • 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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  • Major surgery or radiation therapy completed ≥ 4 weeks prior to enrollment.
  • Clinically immunocompetent. All patients are assumed to be immunocompetent unless they have been diagnosed as being immunosuppressed, are receiving oral steroids, immunosuppressive chemotherapy for oncology disorders or are receiving immunosuppressive therapy following transplant.
  • Free of clinically apparent autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's disease, Hashimoto's thyroiditis, multiple sclerosis, insulin dependant diabetes mellitus or systemic (non-joint) manifestations of rheumatoid disease).
  • Absolute Lymphocyte Count ≥ 500/µl, ANC >1200/µl, Platelet count >100,000/µl, Hemoglobin > 8 mg/dl
  • No evidence of active ischemia on ECG

Who cannot join

  • 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
  • Major surgery or radiation therapy completed ≤ 4 weeks prior to enrollment.
  • 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 and are considered by their physician to be at least less than 30% risk of relapse.
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  • Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled.
  • Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
  • Liver function tests (ALT, AST) more than 1.5 x upper limit of normal (ULN). 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) in Patients With Progressive Hormone Refractory Prostate Cancer

To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.

Read the detailed description

Prostate cancer is the second leading cause of cancer death in American men. Hormonal ablation, in the form of medical or surgical castration is the cornerstone of management for metastatic prostate cancer however, treatment options for a patient in whom androgen ablation fails are limited. Second-line hormonal agents are generally associated with low response rates and no documented survival benefit.

Historically, chemotherapy was not considered to have significant activity in hormone refractory prostate cancer (HRPCa). This view has changed within the past 10 years, partly because of the availability of prostate-specific antigen (PSA) measurements to monitor tumor burden. Although it seems that chemotherapy, either as a single agent or combination of agents may lead to clinical responses, reduction in PSA measurements, pain control, or improved quality of life, no benefit in overall survival has been definitively proven. The current standard of care for the treatment of metastatic prostate cancer is hormone therapy (androgen blockade).3,4 When this strategy is no longer effective, few good treatment options are left. For this reason, prostate cancer research has aimed to identify new therapeutic modalities to increase the impact of these parameters as well as prolong patient survival.

A total of 24 men with prostate cancer ranging from non-metastatic rising PSA only disease to bony metastatic disease will be enrolled in the study. All patients will have failed androgen treatment and at least one prior taxane chemotherapy or have refused chemotherapy.

Out of the 24 patients, 12 patients will be treated using TroVax® and 12 will be treated using TroVax® plus GM-CSF.

Being tested
TroVax, GM-CSF
Keywords
Prostate cancer, hormone refractory prostate cancer, androgen resistant prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • TroVaxBiological

    11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.

  • GM-CSFDrug

    Also called Leukine

    168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).

Study groups in NCT00448409
Study groupRoleWhat they receive
1ExperimentalTroVax alone
Receives: Biological: TroVax
2ExperimentalTroVax plus GM-CSF
Receives: Biological: TroVax; Drug: GM-CSF

What is being measured

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

  1. PSA response rate to TroVax® and TroVax® in combination with GM-CSF

    Measured: restaging every 8 weeks

  2. Anti-5T4 antibody levels

    Measured: 1st 2 cycles every 2 wks; thereafter about every 4 wks

  3. CD8+ve cellular response to 5T4 antigen as measured by Elispot

    Measured: at end of study

  4. Assessment of the number of adverse events and serious adverse events in both groups

    Measured: AEs as occur

Secondary outcomes (4)

  1. Objective response rate

    Measured: restaging every 8 weeks

  2. Overall survival of the patients

    Measured: restaging every 8 weeks

  3. Progression-free survival

    Measured: restaging every 8 weeks

  4. Time to progression

    Measured: restaging every 8 weeks

Timeline

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

  1. First posted16 Mar 2007 (estimated)
  2. Study startMay 2006
  3. Primary completionApr 2007
  4. Study completionMay 2007

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448409
Sponsor's protocol ID
HMRI IRB#0106-0009
Other IDs
TV/PHRPC-001/06
Status last verified
Mar 2016
First submitted
14 Mar 2007
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TroVax and GM-CSF 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 19 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 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 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?

PSA response rate to TroVax® and TroVax® in combination with GM-CSF (time frame: restaging every 8 weeks). The study lists 4 primary outcomes in all. 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 NCT00448409.

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.

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