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

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00091273
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 9
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Primary Peritoneal Cavity Cancer	Biological: incomplete Freund's adjuvant; Biological: ovarian cancer peptide vaccine; Biological: sargramostim; Biological: tetanus toxoid helper peptide; Procedure: adjuvant therapy	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Safety of the Vaccine [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.

2. Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay [Day 22]

Secondary Outcome Measures

1. Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay [Days 1,8,15,22,29,36,43,50 and Month 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia Cancer Center	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Amir A. Jazaeri, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amir Jazaeri, Principal Investigator, University of Virginia
• ClinicalTrials.gov Identifier: NCT00091273
• Other Study ID Numbers: 11276; UVACC-OVA3; UVACC-33204
• First Posted: Sep 9, 2004
• Last Update Posted: Jun 20, 2014
• Last Verified: May 1, 2014

• Keywords provided by Amir Jazaeri, Principal Investigator, University of Virginia: stage I ovarian epithelial cancer; stage II ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; primary peritoneal cavity cancer
• Additional relevant MeSH terms: Sargramostim; Freund's Adjuvant

Study Results

Participant Flow

Arm/Group Title	Single Arm
Arm/Group Description
Period Title: Overall Study
STARTED	9
COMPLETED	9
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Arm
Arm/Group Description
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 77.8%
>=65 years	2 22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (13)
Sex: Female, Male (Count of Participants)
Female	9 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Safety of the Vaccine
Description	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

Outcome Measure Data

Analysis Population Description

All treated subjects were assessed.

Arm/Group Title	Single Arm
Arm/Group Description
Measure Participants	9
# of Subjects Experiencing a DLT	0 0%
# of Subjects Not Experiencing a DLT	9 100%

2. Primary Outcome

Title	Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

All treated subjects were assessed.

Arm/Group Title	Single Arm
Arm/Group Description
Measure Participants	9
Responders	8 88.9%
Non-responders	1 11.1%

3. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

All treated subjects were assessed.

Arm/Group Title	Single Arm
Arm/Group Description
Measure Participants	9
Responders	8 88.9%
Non-responders	1 11.1%

Adverse Events

Time Frame	Days 1-50
Arm/Group Title	Single Arm
Arm/Group Description
All Cause Mortality
	Single Arm
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	0/9 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm
	Affected / at Risk (%)	# Events
Total	9/9 (100%)
Blood and lymphatic system disorders
Hemoglobin	4/9 (44.4%)
Leukocytes	1/9 (11.1%)
Lymphopenia	2/9 (22.2%)
Gastrointestinal disorders
Anorexia	1/9 (11.1%)
Dehydration	1/9 (11.1%)
Diarrhea	1/9 (11.1%)
Mucositis (Clinical Exam) - Oral Cavity	1/9 (11.1%)
Mucositis (Funct/Sympt) - Oral Cavity	1/9 (11.1%)
Nausea	4/9 (44.4%)
Vomiting	3/9 (33.3%)
General disorders
Fatigue	7/9 (77.8%)
Fever	1/9 (11.1%)
Rigors/Chills	2/9 (22.2%)
Sweating	2/9 (22.2%)
Pain - Abdomen NOS	1/9 (11.1%)
Pain - Head/Headache	6/9 (66.7%)
Pain - Joint	2/9 (22.2%)
Pain - Muscle	3/9 (33.3%)
Hepatobiliary disorders
AST	2/9 (22.2%)
Alkaline Phosphatase	1/9 (11.1%)
Creatinine	3/9 (33.3%)
Immune system disorders
Autoimmune Reaction	2/9 (22.2%)
Metabolism and nutrition disorders
Hypercalcemia	1/9 (11.1%)
Hyperglycemia	3/9 (33.3%)
Hyperkalemia	3/9 (33.3%)
Hypoalbuminemia	1/9 (11.1%)
Hypocalcemia	1/9 (11.1%)
Hypokalemia	1/9 (11.1%)
Hypomagnesemia	1/9 (11.1%)
Nervous system disorders
Dizziness	4/9 (44.4%)
Neuropathy-Sensory	1/9 (11.1%)
Respiratory, thoracic and mediastinal disorders
Cough	1/9 (11.1%)
Skin and subcutaneous tissue disorders
Bruising	2/9 (22.2%)
Flushing	2/9 (22.2%)
Injection Site Reaction	9/9 (100%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.