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

NCT ID: NCT00373217

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-13
• Study Completion Date: 2008-02-07

Brief 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.

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine

Intervention Type: BIOLOGICAL

Given intradermally or subcutaneously

tetanus toxoid helper peptide

Intervention Type: BIOLOGICAL

Given intradermally or subcutaneously

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

conventional surgery

Intervention Type: PROCEDURE

Patients undergo primary optimal cytoreductive surgery

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.

Group Type: EXPERIMENTAL

MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine

Intervention Type: BIOLOGICAL

Given intradermally or subcutaneously

tetanus toxoid helper peptide

Intervention Type: BIOLOGICAL

Given intradermally or subcutaneously

carboplatin

Intervention Type: DRUG

Given IV

paclitaxel

Intervention Type: DRUG

Given IV

conventional surgery

Intervention Type: PROCEDURE

Patients undergo primary optimal cytoreductive surgery

Interventions

MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine

Given intradermally or subcutaneously

Intervention Type: BIOLOGICAL

tetanus toxoid helper peptide

Given intradermally or subcutaneously

Intervention Type: BIOLOGICAL

carboplatin

Given IV

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

conventional surgery

Patients undergo primary optimal cytoreductive surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• Short-term therapy for acute conditions not specifically related to ovarian cancer is allowed

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Craig L Slingluff, Jr

OTHER

Sponsor Role: lead

Responsible Party

Craig L Slingluff, Jr

Professor of Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Craig L Slingluff, MD

Role: STUDY_DIRECTOR

University of Virginia

Locations

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

UVACC-OVA-2

Identifier Type: -

Identifier Source: secondary_id

UVACC-PRC-236-02

Identifier Type: -

Identifier Source: secondary_id

10134

Identifier Type: -

Identifier Source: org_study_id