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| ID | Type | Description | Link |
|---|---|---|---|
| UVACC-OVA-2 | |||
| UVACC-PRC-236-02 |
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Slow enrollment rate.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: This is an open-label study. Patients are assigned to 1 of 2 treatment groups.
Group 1:
Group 2:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine | Biological | Given intradermally or subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | weeks 4-28 for group 1, week 4-16 for group 2 |
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DISEASE CHARACTERISTICS:
Diagnosis of ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer
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:
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)
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
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| Name | Affiliation | Role |
|---|---|---|
| Craig L Slingluff, MD | University of Virginia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Adjuvant | 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. Chemotherapy 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after chemotherapy and surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-24, then 3 more vaccines are administered week 23-25. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| tetanus toxoid helper peptide | Biological | Given intradermally or subcutaneously |
|
| carboplatin | Drug | Given IV |
|
| paclitaxel | Drug | Given IV |
|
| conventional surgery | Procedure | Patients undergo primary optimal cytoreductive surgery |
|
| 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. | from study entry to end of protocol treatment. |
| FG001 | Group 2: Neoadjuvant | 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-12, then 3 more vaccines are administered week 14-16. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery |
| BG001 | 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | through week 3 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Participants evaluated for immune response during chemotherapy and/or during vaccine course 2. One participant in adjuvant arm (1) came off study after week 3 and was not evaluable for this endpoint. | Posted | Count of Participants | Participants | weeks 4-28 for group 1, week 4-16 for group 2 |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | T cell responses to tumor cells in vitro have not been analyzed and those analyses are not expected to be completed. Funding ended. | Posted | from study entry to end of protocol treatment. |
|
30 days after last study intervention, up to 18 months after enrollment.
CTCAE
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Adjuvant | 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. Chemotherapy 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after chemotherapy and surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-24, then 3 more vaccines are administered week 23-25. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | Group 2: Neoadjuvant | 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-12, then 3 more vaccines are administered week 14-16. | 0 | 3 | 0 | 3 | 3 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site reaction | Skin and subcutaneous tissue disorders | CTCAE | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Slingluff MD, Professor of Surgery | University of Virginia | 4349249311 | cls8h@virginia.edu |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C072011 | MAGEA1 protein, human |
| D020794 | Receptor Protein-Tyrosine Kinases |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Group 2: Neoadjuvant | 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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-12, then 3 more vaccines are administered week 14-16. |
|
|
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. MAGE-A1, Her-2/neu, FBP peptides ovarian cancer vaccine: Given intradermally or subcutaneously tetanus toxoid helper peptide: Given intradermally or subcutaneously carboplatin: Given IV paclitaxel: Given IV conventional surgery: Patients undergo primary optimal cytoreductive surgery Vaccines are administered after surgery, on weeks 0, 1, 2. Carboplatin and paclitaxel are administered weeks 3-12, then 3 more vaccines are administered week 14-16. |
|