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

NCT00091273 | Completed Phase 1 Results DMC

• 3 other identifiers: 11276UVACC-OVA3UVACC-33204
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay

  Days 1,8,15,22,29,36,43,50 and Month 3

Interventions

incomplete Freund's adjuvant BIOLOGICAL

ovarian cancer peptide vaccine BIOLOGICAL

sargramostim BIOLOGICAL

tetanus toxoid helper peptide BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

incomplete Freund's adjuvant; sargramostim; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Craig L. Slingluff, MD
• Organization: University of Virginia

cls8h@virginia.edu

434-924-1730

Study Officials

• Amir A. Jazaeri, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: June 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: June 1, 2007
• Last Updated: June 20, 2014
• Results First Posted: June 20, 2014

Record last verified: 2014-05

Locations

US (1)