Prostate CancerPhase 1NCT00616291
Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer
A Phase 1 study testing NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine in people with Prostate Cancer, run by Baylor College of Medicine at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jul 2011
- Phase
- Phase 1
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer with evidence of progressive disease despite hormonal therapy (i.e., hormone-refractory prostate cancer)
- Metastatic disease
- Progressive disease defined by any of the following:
- New bone lesion on bone scan
- Progression of nodal or soft tissue as evidenced by standard radiographic methods, i.e., CT scan or MRI
- A 50% increase in PSA level from the nadir PSA level confirmed twice and measured at least 2 weeks apart, with stable and measurable disease
- Castrate serum levels of testosterone < 50 ng/dL
- If patient was receiving anti-androgen therapy, in addition to luteinizing hormone-releasing hormone (LHRH) agonist therapy, the evidence of progressive disease should persist after a trial of anti-androgen withdrawal
- Treatment with LHRH agonist to maintain androgen ablation must continue throughout this trial
- Baseline PSA ≥ 10 ng/mL
- All patients with androgen-independent prostate cancer and matched HLA typing are eligible for vaccination regardless of initial NY-ESO-1 expression status
- Patients must be typed for HLA-DR4, DR13, DP4, or HLA-A2 haplotypes
- No active brain metastases
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 10 mg/dL
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- SGPT ≤ 3 times upper limit of normal
- Serum creatinine ≤ 2 mg/dL
- Wiling to be followed at Baylor College of Medicine
- No serious intercurrent medical illness
- No history of primary or secondary immunodeficiency
- No active systemic infection
- No known hepatitis B surface antigen, hepatitis C, or HIV antibody positivity
- No history of cardiac arrhythmia or ischemic heart disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior immunotherapy (including anti-androgen therapy) and recovered
- More than 28 days since prior chemotherapy
- No concurrent immunosuppressive drugs such as systemic corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.
Secondary
- Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
- Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
- Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.
OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
- Conditions
- Prostate Cancer
- Being tested
- NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine
- Keywords
- recurrent prostate cancer, stage IV 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.
NY-ESO-1/LAGE-1 HLA class I/II peptide vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | MHC Class I binding peptide at 1000 mcg Receives: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine |
| Group II | Experimental | MHC Class II binding peptide at 1000 mcg Receives: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine |
| Group III | Experimental | Combination MHC Class I and II binding peptide at 1000 mcg each Receives: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Toxicity
Secondary outcomes (1)
Immunological response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startApr 2006
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Teresa Hayes, Baylor College of Medicine
- Investigators
- Teresa G. Hayes, MD, PhD, Study chair, Veterans Affairs Medical Center - Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616291
- Sponsor's protocol ID
- CDR0000579579
- Other IDs
- P50CA058204, BCM-H-17274, BCM-SPORE-11-01-30-14
- Status last verified
- Nov 2012
- First submitted
- 14 Feb 2008
- Last updated
- 6 Nov 2012
- Results posted
- No
Publications
Sonpavde G, Wang M, Peterson LE, Wang HY, Joe T, Mims MP, Kadmon D, Ittmann MM, Wheeler TM, Gee AP, Wang RF, Hayes TG. HLA-restricted NY-ESO-1 peptide immunotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2014 Apr;32(2):235-242. doi: 10.1007/s10637-013-9960-9. Epub 2013 Apr 23.
PubMed 23609828
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of Patients With Androgen-Independent Prostate Carcinoma Using NY-ESO-1/LAGE1 Peptide Vaccine (SPORE #: 11-01-30-14)
- ClinicalTrials.gov ID
- NCT00616291
- Acronym / sponsor ID
- CDR0000579579
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Feb 2008 (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.
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.
Secondary
- Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.
- Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.
- Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.
OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccineMHC Class I binding peptide at 1000 mcg |
| Group II | Experimental | Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccineMHC Class II binding peptide at 1000 mcg |
| Group III | Experimental | Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccineCombination MHC Class I and II binding peptide at 1000 mcg each |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine | Biological | Group I, Group II, Group III |
Primary outcome
Tolerability
Toxicity
1 secondary outcome
Immunological response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Derived from this study: PubMed 23609828Sonpavde G, Wang M, Peterson LE, Wang HY, Joe T, Mims MP, Kadmon D, Ittmann MM, Wheeler TM, Gee AP, Wang RF, Hayes TG. HLA-restricted NY-ESO-1 peptide immunotherapy for metastatic castration resistant prostate cancer. Invest New Drugs. 2014 Apr;32(2):235-242. doi: 10.1007/s10637-013-9960-9. Epub 2013 Apr 23.
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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.
Teresa G. Hayes, MD, PhD study chair
Veterans Affairs Medical Center - Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine in people with Prostate Cancer, run by Baylor College of Medicine 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?
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 6 Nov 2012. 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 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.
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?
Tolerability. The study lists 2 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 NCT00616291, 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 6 Nov 2012.