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Recurrent Prostate CarcinomaPhase 2NCT00108732

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

A Phase 2 study testing Bicalutamide, Goserelin Acetate and Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine in people with Recurrent Prostate Carcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 7 sites 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

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Bicalutamide, Goserelin Acetate and Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
7 sitesUnited States
Study dates
Feb 2006to Oct 2010
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

  • Patients with histologically proven prostate cancer and tumors limited to the prostate (including seminal vesical involvement, provided all visible disease was surgically removed) that have completed local therapy and have an elevated PSA after surgery or rising PSA after radiation therapy, as defined below; patients with lymph node involvement (D1) are not eligible
  • Histologically confirmed diagnosis of prostate cancer
  • Previous treatment with definitive surgery or radiation therapy or both
  • No evidence of metastatic disease on physical exam, CT (MRI), and bone scan within 4 weeks prior to randomization
  • Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used >= 1 year prior to enrollment (no prior vaccine/immunotherapy for prostate cancer will be allowed)
  • No therapy modulating testosterone levels (such as leuteinizing-hormone releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year prior to enrollment; agents such as 5-reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, and herbal products are not permitted at any time during the period that the PSA values are being collected
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  • Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150 ng/dL at the time of enrollment within 4 weeks prior to randomization
  • There must be one PSA measurement (referred to as the baseline PSA) obtained within one week prior to registration; the baseline PSA value must be greater than 0.4 ng/mL (after prostatectomy) or greater than 1.5 ng/mL (after radiation therapy)
  • All patients must have evidence of biochemical progression as determined by 3 PSA measurements (PSA1, PSA2, PSA3), each higher than the previous value, each obtained at least 4 weeks apart from the others with the most recent one (PSA3) being the baseline PSA; all of these PSA values must be obtained at the same reference lab; the earliest (PSA1) must be done within 6 months prior to registration.
  • PSA doubling time (PSADT) must be less than 12 months, calculated using the following formula:
  • PSADT in days = (0.693 (t))/(In (PSA3) - In (PSA2)) Where t = the number of days between PSA3 and PSA2 In = the natural log PSADT in months = PSADT in days divided by 30.4375
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
  • Leukocytes >= 3000/mm^³
  • Granulocytes >= 1500/mm^3
  • Platelet count >= 100,000/mm^3
  • Serum creatinine within normal institutional limits or creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal (a calculated clearance may be used); an initial urine analysis will be required with grade 0 proteinuria and no abnormal sediment; for any positive protein a 24 hour urine should be less than 1,000 mg per 24 hours and no indication of chronic renal disease
  • Serum total bilirubin, and alkaline phosphatase within normal institutional limits
  • SGOT (AST) and SGPT (ALT) =< 2.5 x institutional upper limit of normal
  • Patients cannot have evidence of immunosuppression:
  • Patients must be human immunodeficiency virus sero-negative due to the potential for severe reactions to vaccinia and the need for an intact immune system to respond to the immunization
  • Patients must not have active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematous, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease; patients with a history of autoimmunity that has required systemic immunosuppressive therapy or has impaired organ function including CNS, heart, lungs, kidneys, skin, and GI tract are ineligible; patients receiving replacement thyroid hormone would be eligible
  • No concurrent use of systemic steroids, except for local (topical, nasal, or inhaled) steroid use; steroid eye drops are contraindicated for at least 2 weeks before vaccinia vaccination and at least 4 weeks post vaccinia vaccination
  • Patients must be hepatitis B and hepatitis C negative
  • Patients must have a normal PT/INR within 4 weeks prior to randomization
  • Patients must not be receiving any other investigational agents or receiving concurrent anticancer therapy
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; because of the recently recognized risk of cardiac inflammation after vaccinia, patients with clinically significant cardiomyopathy are excluded; patients must have recovered from any intercurrent illness and any acute toxicity related to prior therapy (i.e., surgery and/or radiation)
  • Patients must use a safe and effective method of contraception to prevent virus transmission; the potential risk to spermatogenesis and fetal development after paternal immunization with this vaccine is not known; patients must agree to avoid fathering a child and use a latex barrier with adequate contraception prior to study entry and for at least 4 months following the last vaccine injection
  • All sites of disease must be evaluated within 4 weeks prior to registration
  • Patients with significant allergy or hypersensitivity to eggs should be excluded; patients must not have a history of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen
  • Patients must not have active eczema, a history of eczema, atopic dermatitis, or Darier.s disease; other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis, herpes or other open rashes or wounds
  • Patients must be able to avoid close contact with those who share housing or have close physical contact for at least three weeks after recombinant vaccinia vaccination with persons at increased risk including those with active or a history of eczema or atopic dermatitis, or Darier"s disease; those with other acute, chronic or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, contact dermatitis, psoriasis, herpes or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), which includes those infected with HIV until the condition resolves

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • New York University Langone Medical Center

    New York, New York, 10016

Other trials in United States

About this study

Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Androgens can cause the growth of prostate cancer cells. Drugs, such as bicalutamide and goserelin, may stop the adrenal glands from making androgens in patients whose tumor cells continue to grow. Giving vaccine therapy together with GM-CSF and, when needed, androgen ablation may be a more effective treatment for prostate cancer. This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with prostate cancer that progressed after surgery and/or radiation therapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the effect of PROSTVAC-V/TRICOM (Vaccinia) on cycle 1 followed by PROSTVAC-F/TRICOM (Fowlpox) and GM-CSF on biochemical PSA progression at 6 months.

II. To determine the change in PSA velocity pre-treatment to post-treatment.

SECONDARY OBJECTIVES:

  1. To evaluate the percentage of patients experiencing a >50% decline in serum PSA repeated at 4 weeks.

II. To evaluate tolerability and any toxicity related to treatment with PSA vaccine and GM-CSF.

III. To determine the effect of GM-CSF on PSA immediately after treatment (day 4) compared to a delayed effect (day 15).

IV. To determine the PSA nadir, and percentage of patients with undetectable PSA, treated with combined vaccine and androgen ablation therapy over 12 months.

OUTLINE: This is a multicenter study.

Patients receive vaccinia-PSA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 during weeks 1-4. Beginning in week 5, patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses (weeks 5-16). Beginning in week 17, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.

Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the absence of further clinical or biochemical disease progression.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 6 months.

Being tested
Bicalutamide, Goserelin Acetate, Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine, Recombinant Vaccinia-TRICOM Vaccine, Sargramostim
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • BicalutamideDrug

    Also called Casodex, Cosudex, ICI 176,334, ICI 176334

    Given orally

  • Goserelin AcetateDrug

    Also called ZDX, Zoladex

    Given SC

  • Recombinant Fowlpox-PSA(L155)/TRICOM VaccineBiological

    Also called PROSTVAC-F, rFowlpox-PSA(L155)/TRICOM Vaccine

    Given SC

  • Recombinant Vaccinia-TRICOM VaccineBiological

    Also called rV-TRICOM, Vaccinia-TRICOM, vaccinia-TRICOM vaccine

    Given SC

  • SargramostimBiological

    Also called 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine

    Given SC

Study groups in NCT00108732
Study groupRoleWhat they receive
Treatment (vaccine therapy)ExperimentalPatients receive vaccinia-PSA-TRICOM vaccine SC on day 1 and sargramostim (GM-CSF) SC on days 1-4 during weeks 1-4. Beginning in week 5, patients receive fowlpox-PSA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox-PSA-TRICOM vaccine and GM-CSF repeats every 4 weeks for 3 courses (weeks 5-16). Beginning in week 17, patients receive fowlpox-PSA-TRICOM vaccine and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity. Patients with biochemical or clinical disease progression receive androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox-PSA-TRICOM vaccine and GM-CSF. Treatment continues in the absence of further clinical or biochemical disease progression.
Receives: Drug: Bicalutamide; Drug: Goserelin Acetate; Biological: Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine; Biological: Recombinant Vaccinia-TRICOM Vaccine; Biological: Sargramostim

What is being measured

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

  1. Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)

    For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater.

    Changes in PSA below 5 ng/mL will not be considered assessable for progression.

    For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL.

    Measured: Assessed at 6 months

Secondary outcomes (3)

  1. Proportion of Patients With PSA Response

    PSA response is defined as complete biochemical response or partial response.

    Complete Response:

    A PSA < 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA < 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only.

    Partial Response:

    A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later.

    Measured: Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months

  2. Difference Between Day 4 PSA Level and Day 15 PSA Level

    PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.

    Measured: Assessed at day 4 and day 15 of cycle 1

  3. The Difference Between PSA Slopes Before and After Treatment

    PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.

    Measured: Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months

Timeline

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

  1. First posted19 Apr 2005 (estimated)
  2. Study startFeb 2006
  3. Primary completionOct 2010
  4. Study completionOct 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00108732
Sponsor's protocol ID
NCI-2012-03075
Other IDs
NCI-2012-03075, ECOG-E9802, E9802, E9802, U10CA021115
Status last verified
Dec 2013
First submitted
18 Apr 2005
Last updated
30 Jun 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bicalutamide, Goserelin Acetate and Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine in people with Recurrent Prostate Carcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) 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 31 inclusion and 0 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 30 Jun 2015. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2013). 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?

Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation) (time frame: Assessed at 6 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 NCT00108732.

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 30 Jun 2015.

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