Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.

Entry 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

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

Patient Characteristics:

• ECOG performance status 0-2
• Hemoglobin ≥ 8.0 g/dL
• WBC > 3,000/mm³
• Absolute neutrophil count > 1,500/mm³
• 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

Expected Enrollment

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

Outcomes

Cytotoxic T-cell response to vaccine therapy comprising 5 synthetic ovarian cancer-associated peptides, as assessed using peripheral blood during course 1

Cytotoxic T-cell response to vaccine therapy comprising synthetic ovarian cancer-associated peptides, as assessed using peripheral blood during chemotherapy and during course 2
Cytotoxic T-cell response against autologous and/or major histocompatibility complex-matched allogeneic tumor cells pre- and post-treatment

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.

Trial Contact Information

Trial Lead Organizations

University of Virginia Cancer Center

Amir Jazaeri, MD, Principal investigator		Ph: 434-924-1570; 800-223-9173

Registry Information
Official Title		Evaluation of the Immunogenicity of Vaccination with Synthetic Peptides in Adjuvant in Patients with Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Trial Start Date		2006-04-13
Trial Completion Date		2008-08-01 (estimated)
Registered in ClinicalTrials.gov		NCT00373217
Date Submitted to PDQ		2006-04-27
Information Last Verified		2008-11-06
NCI Grant/Contract Number		CA44579

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