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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amir Jazaeri, University of Virginia
ClinicalTrials.gov Identifier:
NCT00373217
First received: September 6, 2006
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine
Biological: tetanus toxoid helper peptide
Drug: carboplatin
Drug: paclitaxel
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Immunogenicity of Vaccination With Synthetic Peptides in Adjuvant in Patients With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Cytotoxic T-cell response to vaccine therapy comprising 5 synthetic ovarian cancer-associated peptides, as assessed using peripheral blood during course 1 [ Time Frame: 2016 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytotoxic T-cell response to vaccine therapy comprising synthetic ovarian cancer-associated peptides, as assessed using peripheral blood during chemotherapy and during course 2 [ Time Frame: 2016 ] [ Designated as safety issue: No ]
  • Cytotoxic T-cell response against autologous and/or major histocompatibility complex-matched allogeneic tumor cells pre- and post-treatment [ Time Frame: 2016 ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: April 2006
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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
Given intradermally or subcutaneously
Biological: tetanus toxoid helper peptide
Given intradermally or subcutaneously
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: conventional surgery
Patients undergo primary optimal cytoreductive surgery
Experimental: Group 2
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
Given intradermally or subcutaneously
Biological: tetanus toxoid helper peptide
Given intradermally or subcutaneously
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Procedure: conventional surgery
Patients undergo primary optimal cytoreductive surgery

Detailed Description:

OBJECTIVES:

  • Determine the immunogenicity of vaccine therapy comprising synthetic ovarian cancer-associated peptides administered with a synthetic tetanus toxoid helper peptide emulsified in Montanide ISA-51 before or after paclitaxel and carboplatin in patients with stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer undergoing optimal cytoreductive surgery.

OUTLINE: This is an open-label study. Patients are assigned to 1 of 2 treatment groups.

  • Group 1:

    • Neoadjuvant chemotherapy:Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgical debulking.
    • Surgical debulking: Patients undergo primary optimal cytoreductive surgery.
    • Vaccine therapy: Within 14 days after surgery, patients receive vaccine therapy comprising synthetic ovarian cancer-associated peptides, MAGE-A1:161-169, FBP:1901-199, Her-2/neu:369-377, MAGE-A1:96-104, and Her-2/neu:754-762, and tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, and 15. Treatment repeats every 14 weeks for 2 courses.
    • Adjuvant chemotherapy: Patients receive 4 courses of paclitaxel and carboplatin as in neoadjuvant chemotherapy after completion of course 1 of vaccine therapy.
  • Group 2:

    • Surgical debulking: Patients undergo up-front optimal cytoreductive surgery. Patients with non-optimal primary debulking may undergo interval debulking surgery within 6 weeks after completing course 4 of adjuvant chemotherapy. If interval debulking surgery is performed, tumor and/or lymph node tissue is collected.
    • Vaccine therapy: Patients receive 2 courses of vaccine therapy as in group 1.
    • Adjuvant chemotherapy: Patients receive paclitaxel and carboplatin as in group 1, neoadjuvant chemotherapy. Treatment repeats every 21 days for up to 8 courses.

Patients undergo periodic blood and tumor tissue collection during study for correlative immunological analysis.

After completion of study treatment, patients with progressive disease are followed at 30 days and then every six months thereafter. All other patients are followed every 3 months for 36 months until disease progression or until another therapy is initiated, and then every six months thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373217

Locations
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Amir A. Jazaeri, MD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: Amir Jazaeri, Associate Professor of Ob-Gyn, University of Virginia
ClinicalTrials.gov Identifier: NCT00373217     History of Changes
Other Study ID Numbers: 10134, UVACC-OVA-2, UVACC-PRC-236-02
Study First Received: September 6, 2006
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
fallopian tube cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 20, 2014