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 - Full Text View

Sponsor:	University of Virginia
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00373217

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 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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Ovarian Cancer Tetanus

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 [ 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 [ Designated as safety issue: No ]
Cytotoxic T-cell response against autologous and/or major histocompatibility complex-matched allogeneic tumor cells pre- and post-treatment [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	April 2006
Estimated Primary Completion Date:	August 2008 (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

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Amir A. Jazaeri, MD

University of Virginia

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amir A. Jazaeri, University of Virginia Cancer Center
ClinicalTrials.gov Identifier:	NCT00373217 History of Changes
Other Study ID Numbers:	CDR0000483131, UVACC-OVA-2, UVACC-HIC-10134, UVACC-PRC-236-02
Study First Received:	September 6, 2006
Last Updated:	February 6, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

fallopian tube cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
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 February 09, 2012