Vaccine Therapy, Paclitaxel, and Carboplatin in Treating Patients Who Are Undergoing Surgery for Stage III or Stage IV Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

NCT00373217 | Terminated Phase 2 Results

• 3 other identifiers: 10134UVACC-OVA-2UVACC-PRC-236-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving vaccine therapy and chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with paclitaxel and carboplatin works in treating patients who are undergoing surgery for stage III or stage IV ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

fallopian tube cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (1)

• Cytotoxic T-cell Response to Vaccine Therapy Comprising 5 Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Course 1

  T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation

  through week 3

Secondary Outcomes (2)

• Cytotoxic T-cell Response to Vaccine Therapy Comprising Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Chemotherapy and During Course 2

  weeks 4-28 for group 1, week 4-16 for group 2

• Cytotoxic T-cell Response Against Autologous and/or Major Histocompatibility Complex-matched Allogeneic Tumor Cells Pre- and Post-treatment

  from study entry to end of protocol treatment.

Study Arms (2)

Group 1

EXPERIMENTAL

Patients in group one will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin in week 1. Treatment may repeat every 3 weeks for up to four courses. They will then undergo surgery to remove as much of the tumor as possible. Within 2 weeks after surgery, patients will receive an injection of the vaccine once a week for 3 weeks. Treatment may repeat every 14 weeks for two courses. After finishing the first course of vaccine therapy, patients will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin every 3 weeks for up to four courses.

Biological: MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine; Biological: tetanus toxoid helper peptide; Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery

Group 2

EXPERIMENTAL

Patients in group two will undergo surgery to remove as much of the tumor as possible. Within 2 weeks after surgery, patients will receive an injection of the vaccine once a week for 3 weeks. Treatment may repeat every 14 weeks for two courses. After finishing the first course of vaccine therapy, patients will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin every 3 weeks for up to eight courses. Some patients may undergo a second surgery within 6 weeks after completing the fourth course of chemotherapy and undergo tumor and/or lymph node tissue collection.

Biological: MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine; Biological: tetanus toxoid helper peptide; Drug: carboplatin; Drug: paclitaxel; Procedure: conventional surgery

Interventions

MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine BIOLOGICAL

Given intradermally or subcutaneously

Group 1; Group 2

tetanus toxoid helper peptide BIOLOGICAL

Given intradermally or subcutaneously

Group 1; Group 2

carboplatin DRUG

Given IV

Group 1; Group 2

paclitaxel DRUG

Given IV

Group 1; Group 2

conventional surgery PROCEDURE

Patients undergo primary optimal cytoreductive surgery

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer * Stage III or IV disease * HLA-A1, -A2, and/or -A3 positive * Must have at least 1 undissected axillary or inguinal lymph node basin * No recurrent disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 8.0 g/dL * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin A1c \< 7% * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * HIV negative * Hepatitis C negative * No known or suspected allergies to any component of the study vaccine * No other concurrent malignancy (except for nonmelanoma skin cancer) unless the patient was curatively treated and has been disease free for ≥ 5 years * No active serious infection * No autoimmune disorder with visceral involvement * No prior or active autoimmune disorders requiring cytotoxic or immunosuppressive therapy * The following immunologic conditions are allowed: * Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) without symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Mild arthritis requiring NSAIDs * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior and no other concurrent chemotherapy, radiotherapy, or immunotherapy (e.g., interferons, tumor necrosis factor, interleukins, or monoclonal antibodies) * More than 4 weeks since prior and no other concurrent investigational agents * More than 4 weeks since prior and no concurrent allergy desensitization injections * More than 4 weeks since prior and no concurrent oral or parenteral systemic corticosteroids * No prior or concurrent inhaled corticosteroids (e.g., fluticasone and salmetrol, fluticasone, or triamcinolone acetonide) * Prior or concurrent topical corticosteroids allowed * No prior vaccination with MAGE-A1:161-169, FBP:1901-199, Her-2/neu:369-377, MAGE-A1:96-104, or Her-2/neu:754-762 * More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim) * No concurrent treatment for recurrent disease * No concurrent nitrosoureas * No concurrent illegal drug use * Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, and chronic medications, unless excluded, are allowed * Short-term therapy for acute conditions not specifically related to ovarian cancer is allowed

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

Sponsors & Collaborators

• Craig L Slingluff, Jr: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

MAGEA1 protein, human; Receptor Protein-Tyrosine Kinases; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Craig Slingluff MD, Professor of Surgery
• Organization: University of Virginia

cls8h@virginia.edu

4349249311

Study Officials

• Craig L Slingluff, MD

  University of Virginia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: April 13, 2006
• Primary Completion: February 7, 2008
• Study Completion: February 7, 2008
• Last Updated: September 21, 2022
• Results First Posted: September 21, 2022

Record last verified: 2022-08

Locations

US (1)