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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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

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

tetanus toxoid helper peptide

carboplatin

paclitaxel

conventional surgery

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring fallopian tube cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University of Virginia Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

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

T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation

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

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.

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.

Full Information

NCT ID

NCT00373217

First Posted

September 6, 2006

Last Updated

August 25, 2022

Sponsor

Craig L Slingluff, Jr

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00373217

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment rate.

Study Start Date

April 13, 2006 (Actual)

Primary Completion Date

February 7, 2008 (Actual)

Study Completion Date

February 7, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Craig L Slingluff, Jr

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

fallopian tube cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

Given intradermally or subcutaneously

Intervention Type

Biological

Intervention Name(s)

tetanus toxoid helper peptide

Intervention Description

Given intradermally or subcutaneously

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Description

Patients undergo primary optimal cytoreductive surgery

Primary Outcome Measure Information:

Title

Cytotoxic T-cell Response to Vaccine Therapy Comprising 5 Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Course 1

Description

T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation

Time Frame

through week 3

Secondary Outcome Measure Information:

Title

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

Description

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

Title

Cytotoxic T-cell Response Against Autologous and/or Major Histocompatibility Complex-matched Allogeneic Tumor Cells Pre- and Post-treatment

Description

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig L Slingluff, MD

Organizational Affiliation

University of Virginia

Official's Role

Study Director

Facility Information:

Facility Name

University of Virginia Cancer Center

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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