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

• Status: Terminated
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig L Slingluff, Jr
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Vaccines

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