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Vaccine Therapy in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00091273
Enrollment
9
Registered
2004-09-09
Start date
2004-06-30
Completion date
2007-06-30
Last updated
2014-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

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.

Interventions

BIOLOGICALincomplete Freund's adjuvant
BIOLOGICALovarian cancer peptide vaccine
BIOLOGICALsargramostim
PROCEDUREadjuvant therapy

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Virginia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Safety of the VaccineDays 1,8,15,22,29,36,43,50Participants 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 AssayDay 22

Secondary

MeasureTime frame
Measure of Tumor-antigen-specific Immunity in PBMC by Elispot AssayDays 1,8,15,22,29,36,43,50 and Month 3

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Arm9
Total9

Baseline characteristics

CharacteristicSingle Arm
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
2 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
Age, Continuous57 years
STANDARD_DEVIATION 13
Region of Enrollment
United States
9 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
9 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

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

Time frame: Day 22

Population: All treated subjects were assessed.

ArmMeasureGroupValue (NUMBER)
Single ArmMeasure of Tumor-antigen-specific Immunity in SIN by ELIspot AssayNon-responders1 participants
Single ArmMeasure of Tumor-antigen-specific Immunity in SIN by ELIspot AssayResponders8 participants
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.

Time frame: Days 1,8,15,22,29,36,43,50

Population: All treated subjects were assessed.

ArmMeasureGroupValue (NUMBER)
Single ArmSafety of the Vaccine# of Subjects Experiencing a DLT0 participants
Single ArmSafety of the Vaccine# of Subjects Not Experiencing a DLT9 participants
Secondary

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

Population: All treated subjects were assessed.

ArmMeasureGroupValue (NUMBER)
Single ArmMeasure of Tumor-antigen-specific Immunity in PBMC by Elispot AssayResponders8 participants
Single ArmMeasure of Tumor-antigen-specific Immunity in PBMC by Elispot AssayNon-responders1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026