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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.

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

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
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

Other trials in United States

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.

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.

  1. 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

  2. Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay

    Measured: Day 22

Secondary outcomes (1)
  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.

  1. First posted9 Sep 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionFeb 2006
  4. Study completionJun 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
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
Data monitoring committee
Yes

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.

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