Trial Outcomes & Findings for Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer (NCT NCT00088985)
NCT ID: NCT00088985
Last Updated: 2017-06-20
Results Overview
Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
6 months following treatment
Results posted on
2017-06-20
Participant Flow
56 patients enrolled; 23 were human leukocyte antigen (HLA:A2) negative, 11 withdrew/refused treatment prior to start, 4 consented/not treated due to study closure, 3 went to a different study, 2 died before treatment, 2 were human epidermal growth factor receptor 2 (HER-2/neu) not detectable, and 4 patients ineligible. 7 patients were evaluable.
Participant milestones
| Measure |
Dendritic Cell Vaccine
Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Dendritic Cell Vaccine
n=7 Participants
Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
Age, Continuous
|
64.43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months following treatmentResponse measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter.
Outcome measures
| Measure |
Dendritic Cell Vaccine
n=7 Participants
Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
Overall Response Rate
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months following treatmentMeasured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy.
Outcome measures
| Measure |
Dendritic Cell Vaccine
n=7 Participants
Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
Immune Response
CD8+ Tetramer Increased
|
7 Participants
|
|
Immune Response
No Change
|
0 Participants
|
Adverse Events
Dendritic Cell Vaccine
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Dendritic Cell Vaccine
n=7 participants at risk
Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
General disorders
Fever
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
Other adverse events
| Measure |
Dendritic Cell Vaccine
n=7 participants at risk
Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab: 4 mg/kg intravenously, every 14 days
vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
General disorders
Edema
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
42.9%
3/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
57.1%
4/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.6%
2/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Investigations
Leukocytes (total WBC)
|
42.9%
3/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Investigations
Lymphopenia
|
57.1%
4/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
57.1%
4/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
General disorders
Pain - Other (Specify)
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
|
Investigations
Platelets
|
14.3%
1/7 • Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place