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AzTrials

Prostatic NeoplasmsPhase 1/2NCT00060528

Sequential Vaccinations in Prostate Cancer Patients

A Phase 1/2 study testing Recombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) and Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM) in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) 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

Background: " Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death. " Vaccine strategies represent a novel therapeutic approach in the treatment for 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?
Recombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) and Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
22 May 2003to 8 Jun 2009
Phase
Phase 1/2
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 must have histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), or National Naval Medical Center (NNMC) prior to starting this study.
  • If no pathologic specimen is available to the NCI or NNMC, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
  • Patients must have androgen insensitive metastatic prostate cancer.
  • Progression must be documented by at least one of the following parameters:
  • All patients must have received standard of care (hormonal) treatment before entering the trial.
  • All patients will have received and progressed on hormonal therapy for metastatic prostate carcinoma.
Show all 71Show fewer
  • All subjects must have objective evidence of metastasis or relapsing local disease to be eligible for this Phase I trial; therefore, they must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies, as defined below.
  • Two consecutively rising prostatic specific antigen (PSA) levels, separated by at least 1 week, with at least one measurement that is 50% above the nadir reached after the last therapeutic maneuver (as long as the last measurement is 5 ng/ml or greater), and
  • At least one lesion consistent with metastatic cancer on Technetium (Tc)-99 whole body scintigraphy, and/or
  • Soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation).
  • Patients must have a life expectancy of more than 6 months.
  • Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria.
  • Patients must have recovered from any acute toxicity related to prior therapy, including surgery, and radiation (treatment must have been completed at least 4 weeks prior to being eligible for the study).
  • Patients who are responding to hormonal therapy are not eligible until evidence of disease progression.
  • Hematological eligibility parameters (within 16 days of starting therapy):
  • Granulocyte count greater than or equal to 1,500/mm^3
  • Platelet count greater than or equal to 100,000/mm^3
  • Lymphocyte count greater than or equal to 500/mm^3
  • Hemoglobin (Hgb) greater than or equal to 10 Gm/dL
  • Biochemical eligibility parameters (within 16 days of starting therapy):
  • A 24-hour urine collection for baseline to measure creatinine clearance (CrCl), protein and electrolytes.
  • CrCl greater than 60, proteinuria less than 1000 milligrams per 24 hours, less than or equal to Grade 1 (NCI-common toxicity criteria (CTC) version 2.0) proteinuria, Grade 0 hematuria, and no abnormal sediment.
  • Grade 0 creatinine.
  • Patients must have serum creatinine within normal limits.
  • Any abnormalities in the sediment or the presence of hematuria without a likely underlying cause should prompt the investigator to consider an evaluation by a nephrologist for evidence of underlying renal pathology. Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal.
  • Hepatic function: Bilirubin less than 1.5 mg/dl,
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times upper limit of normal.
  • Patients must be test negative for human immunodeficiency virus (HIV), Hepatitis B and C.
  • Patients must not have other active malignancies within the past 2 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.
  • Patients must be willing to travel to the National Institutes of Health (NIH) for follow-up visits.
  • Patients must be greater than or equal to 18 years of age.
  • All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of allergy or untoward reaction to the vaccine. Since vaccinia immunoglobulin (VIG) is available from the Centers for Disease Control (CDC), prior vaccinia vaccination as a safety precaution is no longer required.
  • Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.
  • Patients must not have received the following chemotherapeutic agents for cancer within 3 years of enrolling on study: docetaxel, paclitaxel, doxorubicin, cisplatinum, carboplatinum, mitoxantrone, estramustine, cyclophosphamide, irinotecan, topotecan.
  • Patients must not have received prior PSA vaccine therapy.
  • Patients will tested for human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2). This test may be drawn by the patient's referring physician at the time of referral (see Appendix C, HLA-typing consent). This consent will be mailed to the patient and discussed with patient. The signed consent will be signed with a witness, then mailed to the assigned research nurse at the NIH Clinical Center. These patients must have measurable disease on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan.
  • The effects of the study agents used in this protocol on the developing human fetus are unknown. For this reason men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Patients must have histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), or National Naval Medical Center (NNMC) prior to starting this study. If no pathologic specimen is available to the NCI or NNMC, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
  • All patients will have received and progressed on hormonal therapy for metastatic prostate carcinoma.
  • All subjects must have objective evidence of metastasis or relapsing local disease to be eligible; therefore, they must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies, as defined below.
  • Two consecutively rising PSA levels, separated by at least 1 week, with at least one measurement that is 50% above the
  • nadir reached after the last therapeutic maneuver (as long as the last measurement is 5 ng/ml or greater), and
  • At least one lesion consistent with metastatic cancer on Technetium (Tc)-99 whole body scintigraphy, and/or
  • Soft-tissue metastases as measured by appropriate modalities (i.e., imaging, palpation).
  • Patients must have a life expectancy of more than 6 months.
  • Patients must have a performance status of 0 to 2 according to the ECOG criteria.
  • Patients must have recovered from any acute toxicity related to prior therapy, including surgery, and radiation (treatment must have been completed at least 4 weeks prior to being eligible for the study).
  • Hematological eligibility parameters (within 16 days of starting therapy):
  • Granulocyte count greater than or equal to 1,500/mm^3
  • Platelet count greater than or equal to 100,000/mm^3
  • Lymphocyte count greater than or equal to 500/mm^3
  • Hgb greater than or equal to 10 Gm/dL
  • Biochemical eligibility parameters (within 16 days of starting therapy):
  • A 24-hour urine collection for baseline to measure creatinine clearance (CrCl), protein and electrolytes.
  • CrCl greater than 60
  • proteinuria less than 1000 milligrams per 24 hours, less than or equal to Grade 1 (NCI-Common Toxicity Criteria (CTC) version 2.0) proteinuria, Grade 0 hematuria, and no abnormal sediment.
  • Grade 0 creatinine.
  • Patients must have serum creatinine within normal limits.
  • Any abnormalities in the sediment or the presence of hematuria without a likely underlying cause should prompt the investigator to consider an evaluation by a nephrologist for evidence of underlying renal pathology. Patients may be eligible if the underlying cause of the abnormality is determined to be non-renal.
  • Hepatic function: Bilirubin less than 1.5 mg/dl,
  • AST and ALT less than 2.5 times upper limit of normal.
  • Patients must test negative for HIV, Hepatitis B and C.
  • Patients must not have other active malignancies within the past 2 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life threatening illnesses.
  • Patients must be willing to travel to the NIH for follow-up visits.
  • Patients must be greater than or equal to 18 years of age.
  • All patients who have received prior vaccination with vaccinia virus (for smallpox immunization) must not have a history of allergy or untoward reaction to the vaccine. Since vaccinia immunoglobulin (VIG) is available from the CDC, prior vaccinia vaccination as a safety precaution is no longer required.
  • Patients must understand and sign informed consent that explains the neoplastic nature of their disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, potential risks and toxicities, and the voluntary nature of participation.
  • Patients have not received the following chemotherapeutic agents for cancer within 3 years of enrolling on study: docetaxel, paclitaxel, doxorubicin, cisplatinum, carboplatinum, mitoxantrone, estramustine, cyclophosphamide, irinotecan, topotecan.
  • Patients have not received prior PSA vaccine therapy.
  • All patients will tested for HLA-A2. Patients must be HLA-A2+. This test may be drawn by the patient's referring physician at the time of referral (see Appendix C, HLA-typing consent). This consent will be mailed to the patient and discussed with patient. The signed consent will be signed with a witness, then mailed to the assigned research nurse at the National Institutes of Health (NIH) Clinical Center. These patients must have measurable disease on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan.
  • The effects of the study agents used in this protocol on the developing human fetus are unknown. For this reason men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Who cannot join

  • Prior splenectomy.
  • Concurrent steroid use, except topical steroids or inhaled steroid use.
  • The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least 3 weeks after vaccination, their close household contacts:
  • persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves; pregnant or nursing women; children under 5 years of age; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection.
  • Close household contacts are those who share housing or have close physical contact.
  • Patients with known allergy to eggs.
Show all 14Show fewer
  • Other serious intercurrent illness.
  • Patients with brain metastases.
  • Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment) or New York Heart Association class II-IV congestive heart failure.
  • Patients on antiandrogen therapy must undergo antiandrogen withdrawal for at least 4 weeks and still show evidence of a rising PSA.
  • Following treatment with bicalutamide, patients must undergo withdrawal for at least 6 weeks and still show evidence of a rising PSA.
  • Prior treatments with vaccine expressing PSA are NOT eligible.
  • Patients with significant autoimmune disease that is active or potentially life threatening if activated.
  • Patients with clinically significant cardiomyopathy requiring treatment should be excluded from protocol eligibility at this time.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase I/II Pilot Study of Sequential Vaccinations With rFowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) Alone, or in Combination With rVaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), and the Role of GM-CSF, in Men With Prostate Cancer

Background:

" Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.

Read more

" Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.

Objectives:

" The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.

" Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis.

" To document any objective anti-tumor responses that may occur.

Eligibility:

" Patients must have androgen insensitive metastatic prostate cancer.

" All patients will have received and progressed on hormonal therapy.

" Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies.

" Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.

"Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+).

" Granulocyte count greater than or equal to 1,500/mm^3, Platelet greater than or equal to 100,000/mm^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60

" No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness.

Design:

" Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively.

"This study will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF.

"This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.

The maximum accrual to the trial should be 62.

Read the detailed description

Background:

  • Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.
  • Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.

Objectives:

  • The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.
  • Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis.
  • To document any objective anti-tumor responses that may occur.

Eligibility:

  • Patients must have androgen insensitive metastatic prostate cancer.
  • All patients will have received and progressed on hormonal therapy.
  • Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies.
  • Must have a life expectancy of more than 6 months and the Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
  • Patients must be HLA-A2+.
  • Granulocyte count greater than or equal to 1,500/mm^3, Platelet greater than or equal to 100,000/mm^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm^3; Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60
  • No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness.

Design:

  • Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively.
  • This study will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant GM-CSF, or with either of 2 doses of fowlpox-GM-CSF.
  • This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.
Being tested
Recombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM), Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM), Recombinant Human GM-CSF
Keywords
Immunotherapy, Cytokines, Immune Assays, 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.

  • Recombinant Fowlpox-GM-CSFDrug

    Also called rF-GMCSF

  • Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM)Drug

    Also called PROSTVAC-F (fowlpox)/TRICOM

  • Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM)Drug

  • Recombinant Human GM-CSFDrug

Study groups in NCT00060528
Study groupRoleWhat they receive
no GMExperimentalNo granulocyte macrophage colony stimulating factor (GM-CSF) was given
Receives: Drug: Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM)
Rec-hGMExperimentalRecombinant human GM-CSF (Sargramostim) was administered at 100mcg/day on days 1-4 following each vaccine. Given subcutaneously (s.c.) at site of vaccine.
Receives: Drug: Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM); Drug: Recombinant Human GM-CSF
rF-GM (10^7pfu)Experimentalrecombinant fowlpox GM-CSF was given on day one at 10^7 in last two arms. Given subcutaneously (s.c.) at site of vaccine.
Receives: Drug: Recombinant Fowlpox-GM-CSF; Drug: Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM); Drug: Recombinant Human GM-CSF
rF-GM (10^8)Experimentalrecombinant fowlpox GM-CSF was given on day one at 10^8 in last two arms. Given subcutaneously (s.c.) at site of vaccine.
Receives: Drug: Recombinant Fowlpox-GM-CSF; Drug: Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM); Drug: Recombinant Human GM-CSF

What is being measured

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

  1. Number of Participants With an Immune Response

    Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.

    Measured: 48 months

Secondary outcomes (4)

  1. Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels

    PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)

    Measured: 53 months

  2. Number of Participants With an Objective Response

    Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...

    Measured: 53 months

  3. Overall Survival

    Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up.

    Measured: 50 months

  4. The Number of Participants With Adverse Events

    Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

    Measured: 77.5 months

Timeline

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

  1. First posted7 May 2003 (estimated)
  2. Study start22 May 2003
  3. Primary completion7 Mar 2006
  4. Study completion8 Jun 2009

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060528
Sponsor's protocol ID
030176
Other IDs
03-C-0176
Status last verified
Sep 2017
First submitted
7 May 2003
Last updated
26 Oct 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Correale P, Walmsley K, Nieroda C, Zaremba S, Zhu M, Schlom J, Tsang KY. In vitro generation of human cytotoxic T lymphocytes specific for peptides derived from prostate-specific antigen. J Natl Cancer Inst. 1997 Feb 19;89(4):293-300. doi: 10.1093/jnci/89.4.293.

    PubMed 9048833

  • Vergati M, Cereda V, Madan RA, Gulley JL, Huen NY, Rogers CJ, Hance KW, Arlen PM, Schlom J, Tsang KY. Analysis of circulating regulatory T cells in patients with metastatic prostate cancer pre- versus post-vaccination. Cancer Immunol Immunother. 2011 Feb;60(2):197-206. doi: 10.1007/s00262-010-0927-9. Epub 2010 Oct 26.

    PubMed 20976449

  • Yokokawa J, Cereda V, Remondo C, Gulley JL, Arlen PM, Schlom J, Tsang KY. Enhanced functionality of CD4+CD25(high)FoxP3+ regulatory T cells in the peripheral blood of patients with prostate cancer. Clin Cancer Res. 2008 Feb 15;14(4):1032-40. doi: 10.1158/1078-0432.CCR-07-2056.

    PubMed 18281535

  • Gulley JL, Arlen PM, Madan RA, Tsang KY, Pazdur MP, Skarupa L, Jones JL, Poole DJ, Higgins JP, Hodge JW, Cereda V, Vergati M, Steinberg SM, Halabi S, Jones E, Chen C, Parnes H, Wright JJ, Dahut WL, Schlom J. Immunologic and prognostic factors associated with overall survival employing a poxviral-based PSA vaccine in metastatic castrate-resistant prostate cancer. Cancer Immunol Immunother. 2010 May;59(5):663-74. doi: 10.1007/s00262-009-0782-8. Epub 2009 Nov 5.

    PubMed 19890632

  • Stein WD, Gulley JL, Schlom J, Madan RA, Dahut W, Figg WD, Ning YM, Arlen PM, Price D, Bates SE, Fojo T. Tumor regression and growth rates determined in five intramural NCI prostate cancer trials: the growth rate constant as an indicator of therapeutic efficacy. Clin Cancer Res. 2011 Feb 15;17(4):907-17. doi: 10.1158/1078-0432.CCR-10-1762. Epub 2010 Nov 24.

    PubMed 21106727

  • Smith HA, Maricque BB, Eberhardt J, Petersen B, Gulley JL, Schlom J, McNeel DG. IgG responses to tissue-associated antigens as biomarkers of immunological treatment efficacy. J Biomed Biotechnol. 2011;2011:454861. doi: 10.1155/2011/454861. Epub 2010 Dec 19.

    PubMed 21197272

  • Kim JW, Madan RA, Gulley JL. Initial PSA oscillations precede prolonged stable disease in a patient treated with a therapeutic cancer vaccine. Clin Genitourin Cancer. 2012 Mar;10(1):43-6. doi: 10.1016/j.clgc.2011.09.003. Epub 2011 Oct 21. No abstract available.

    PubMed 22019260

  • Arlen PM, Skarupa L, Pazdur M, Seetharam M, Tsang KY, Grosenbach DW, Feldman J, Poole DJ, Litzinger M, Steinberg SM, Jones E, Chen C, Marte J, Parnes H, Wright J, Dahut W, Schlom J, Gulley JL. Clinical safety of a viral vector based prostate cancer vaccine strategy. J Urol. 2007 Oct;178(4 Pt 1):1515-20. doi: 10.1016/j.juro.2007.05.117. Epub 2007 Aug 16.

    PubMed 17707059

  • Huang J, Jochems C, Talaie T, Anderson A, Jales A, Tsang KY, Madan RA, Gulley JL, Schlom J. Elevated serum soluble CD40 ligand in cancer patients may play an immunosuppressive role. Blood. 2012 Oct 11;120(15):3030-8. doi: 10.1182/blood-2012-05-427799. Epub 2012 Aug 28.

    PubMed 22932804

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Fowlpox-GM-CSF, Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) and Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM) in people with Prostatic Neoplasms, run by National Cancer Institute (NCI) 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 71 inclusion and 14 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 26 Oct 2017. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 23 Feb 2012). 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 an Immune Response (time frame: 48 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 NCT00060528, which also lists 9 linked publications.

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 26 Oct 2017.

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