Ovarian CancerPhase 1NCT00091273
Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer
A Phase 1 study testing incomplete Freund's adjuvant, ovarian cancer peptide vaccine and sargramostim in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- incomplete Freund's adjuvant, ovarian cancer peptide vaccine and sargramostim
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2007
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed ovarian epithelial or primary peritoneal cancer
- Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria:
- Clinical or radiographic evidence of disease
- Serologic evidence of disease
- Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months
- At least 2 intact axillary and/or inguinal lymph node basins
- Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin
- HLA-A1-, -A2-, or -A3-positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 8.0 g/dL OR
- Hematocrit > 25%
- Platelet count ≥ 80,000/mm^3
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
- Hepatitis C negative
Renal
- Not specified
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
- HIV negative
- No active infection requiring antibiotics
- No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- No prior autoimmune disorder with visceral involvement
- No known or suspected allergy to any component of the study vaccine
- The following immunologic conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic
- Clinical evidence of vitiligo or other forms of depigmenting illness
- Mild arthritis requiring non-steroidal anti-inflammatory drugs
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight ≥ 110 lbs
- No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7%
- No active hyperthyroidism
- No current or recent (within the past year) addiction to alcohol or drugs
- No medical contraindication or other potential medical problem that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 2 weeks since prior and no concurrent allergy desensitization injections
- More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim)
- More than 1 month since prior and no other concurrent immunotherapy
- More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following:
- Interferon
- Tumor necrosis factor
- Interleukins or other cytokines
- Biologic response modifiers
- Monoclonal antibodies
- No prior vaccination with all of the study peptides relevant to the patient's HLA-type
Chemotherapy
- See Disease Characteristics
- More than 1 month since prior chemotherapy and recovered
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol)
- Topical corticosteroids allowed
Radiotherapy
- More than 1 month since prior radiotherapy and recovered
Surgery
- See Disease Characteristics
- More than 1 month since prior surgery and recovered
Other
- More than 1 month since other prior treatment and recovered
- More than 1 month since prior and no other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.
Read the detailed description
OBJECTIVES:
- Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer.
OUTLINE: This is an open-label study.
Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43.
After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- incomplete Freund's adjuvant, ovarian cancer peptide vaccine, sargramostim, tetanus toxoid helper peptide, adjuvant therapy
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incomplete Freund's adjuvantBiological
ovarian cancer peptide vaccineBiological
sargramostimBiological
tetanus toxoid helper peptideBiological
adjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Vaccine
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Measured: Days 1,8,15,22,29,36,43,50
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Measured: Day 22
Secondary outcomes (1)
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
Measured: Days 1,8,15,22,29,36,43,50 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startJun 2004
- Primary completionFeb 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Amir Jazaeri, University of Virginia
- Investigators
- Amir A. Jazaeri, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091273
- Sponsor's protocol ID
- 11276
- Other IDs
- UVACC-OVA3, UVACC-33204
- Status last verified
- May 2014
- First submitted
- 7 Sep 2004
- Last updated
- 20 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00091273
- Acronym / sponsor ID
- 11276
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Sep 2004 (estimated)
- Results
- Posted 20 Jun 2014
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 make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with ovarian epithelial or primary peritoneal cancer.
Detailed description
OBJECTIVES:
- Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer.
OUTLINE: This is an open-label study.
Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43.
After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female 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 |
|---|---|---|
| incomplete Freund's adjuvant | Biological | – |
| ovarian cancer peptide vaccine | Biological | – |
| sargramostim | Biological | – |
| tetanus toxoid helper peptide | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
Primary outcome
Safety of the Vaccine
Time frame: Days 1,8,15,22,29,36,43,50
Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.
Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Time frame: Day 22
1 secondary outcome
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay
Time frame: Days 1,8,15,22,29,36,43,50 and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Amir A. Jazaeri, MD principal investigator
University of Virginia
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 incomplete Freund's adjuvant, ovarian cancer peptide vaccine and sargramostim in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by University of Virginia 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 20 Jun 2014. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2014). 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?
Safety of the Vaccine (time frame: Days 1,8,15,22,29,36,43,50). 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?
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 20 Jun 2014.