Trial Outcomes & Findings for 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 NCT00373217)
NCT ID: NCT00373217
Last Updated: 2022-09-21
Results Overview
T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
through week 3
Results posted on
2022-09-21
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Group 1
n=3 Participants
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
|
Group 2
n=3 Participants
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
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
56.4 years
n=5 Participants
|
53.9 years
n=7 Participants
|
55.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through week 3T cell response by interferon-gamma ELIspot assay, after 1 in vitro stimulation
Outcome measures
| Measure |
Group 1: Adjuvant
n=3 Participants
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.
|
Group 2: Neoadjuvant
n=3 Participants
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.
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|---|---|---|
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Cytotoxic T-cell Response to Vaccine Therapy Comprising 5 Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Course 1
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: weeks 4-28 for group 1, week 4-16 for group 2Population: 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.
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.
Outcome measures
| Measure |
Group 1: Adjuvant
n=2 Participants
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.
|
Group 2: Neoadjuvant
n=3 Participants
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.
|
|---|---|---|
|
Cytotoxic T-cell Response to Vaccine Therapy Comprising Synthetic Ovarian Cancer-associated Peptides, as Assessed Using Peripheral Blood During Chemotherapy and During Course 2
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from study entry to end of protocol treatment.Population: T cell responses to tumor cells in vitro have not been analyzed and those analyses are not expected to be completed. Funding ended.
T cell responses to tumor cells in vitro. Note. This has not been done and is not expected to be completed.
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Adjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: Neoadjuvant
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Adjuvant
n=3 participants at risk
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.
|
Group 2: Neoadjuvant
n=3 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
100.0%
3/3 • 30 days after last study intervention, up to 18 months after enrollment.
CTCAE
|
100.0%
3/3 • 30 days after last study intervention, up to 18 months after enrollment.
CTCAE
|
Additional Information
Craig Slingluff MD, Professor of Surgery
University of Virginia
Phone: 4349249311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place