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

NCT00373217TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Craig L Slingluff, Jr

Enrollment

6

Start Date

2006-04-13

Completion Date

2008-02-07

Study Type

INTERVENTIONAL

Official Title

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

Interventions

MAGE-A1Her-2/neuFBP peptides ovarian cancer vaccinetetanus toxoid helper peptidecarboplatinpaclitaxelconventional surgery

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Eligibility

Age Range

18 Years – 120 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: through week 3

Secondary Outcomes

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

T cell response to one or more peptides in peripheral blood by IFN-gamma ELIspot assay during chemotherapy and/or during 2nd course of vaccines.

Time frame: 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

T cell responses to tumor cells in vitro. Note. This has not been done and is not expected to be completed.

Time frame: from study entry to end of protocol treatment.

Locations

University of Virginia Cancer Center, Charlottesville, United States