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| ID | Type | Description | Link |
|---|---|---|---|
| UVACC-OVA3 | |||
| UVACC-33204 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incomplete Freund's adjuvant | Biological | |||
| ovarian cancer peptide vaccine | Biological | |||
| sargramostim | Biological | |||
| tetanus toxoid helper peptide | Biological | |||
| adjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1,8,15,22,29,36,43,50 |
| Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | Days 1,8,15,22,29,36,43,50 and Month 3 |
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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:
At least 2 intact axillary and/or inguinal lymph node basins
HLA-A1-, -A2-, or -A3-positive
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
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:
Other
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:
No prior vaccination with all of the study peptides relevant to the patient's HLA-type
Chemotherapy
Endocrine therapy
More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol)
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Amir A. Jazaeri, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All treated subjects were assessed. | Posted | Number | participants | Days 1,8,15,22,29,36,43,50 |
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| Primary | Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay | All treated subjects were assessed. | Posted | Number | participants | Day 22 |
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| Secondary | Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay | All treated subjects were assessed. | Posted | Number | participants | Days 1,8,15,22,29,36,43,50 and Month 3 |
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Days 1-50
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | 0 | 9 | 9 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autoimmune Reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Rigors/Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Injection Site Reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Mucositis (Funct/Sympt) - Oral Cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| AST | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Alkaline Phosphatase | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Creatinine | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy-Sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain - Abdomen NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain - Head/Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain - Joint | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain - Muscle | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig L. Slingluff, MD | University of Virginia | 434-924-1730 | cls8h@virginia.edu |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C114843 | incomplete Freund's adjuvant |
| C081222 | sargramostim |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Non-responders |
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| Non-responders |
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