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Evaluation of the Immunogenicity of Vaccination With Synthetic Peptides in Adjuvant in Patients With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Evaluation of the Immunogenicity of Vaccination With Synthetic Peptides in Adjuvant in Patients With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Amir A. Jazaeri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000483131

NCT ID:

NCT00373217

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • fallopian tube cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908