Trial Outcomes & Findings for Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer (NCT NCT00971737)
NCT ID: NCT00971737
Last Updated: 2019-04-24
Results Overview
Number of grade 3 or 4 nonhematologic toxicity (except alopecia), or any grade 4 hematologic toxicity as defined by NCI CTCAE v3.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
3 years
Results posted on
2019-04-24
Participant Flow
3 subjects were withdrawn prior to receiving intervention (2 due to development of new medical problems, 1 due to anxiety and non-compliance).
Participant milestones
| Measure |
Cyclophosphamide and Vaccine Only
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Cyclophosphamide and Vaccine Only
n=30 Participants
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
n=30 Participants
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
Total
n=60 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
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
52 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.
Number of grade 3 or 4 nonhematologic toxicity (except alopecia), or any grade 4 hematologic toxicity as defined by NCI CTCAE v3.0
Outcome measures
| Measure |
Cyclophosphamide and Vaccine Only
n=28 Participants
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
n=30 Participants
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
|---|---|---|
|
Toxicity as Assessed by Number of Grade 3 or 4 Adverse Events
|
0 adverse events
|
2 adverse events
|
PRIMARY outcome
Timeframe: 6 months post-interventionPopulation: Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.
Progression-free survival is measured as percentage of participants with stable disease or complete response, as defined by RECIST criteria, six months after receiving last vaccination. Progressive disease (PD) will be defined by the appearance of a new lesion, or by an increase of at least 20% in the sum of the longest diameter of target lesions, taking as a reference that smallest sum longest diameter recorded since the study intervention began. In the case of bone lesions, progressive disease will be established after eight weeks of increasing or new lesions if there is subjective progressive disease as noted by increasing bone pain or decreasing performance status. These observations must be present for at least two measurement periods separated by at least four weeks.
Outcome measures
| Measure |
Cyclophosphamide and Vaccine Only
n=28 Participants
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
n=30 Participants
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
|---|---|---|
|
Clinical Benefit (CB) as Assessed by Progression Free Survival at Six Months
|
33 percentage of participants
Interval 17.0 to 53.0
|
37 percentage of participants
Interval 20.0 to 56.0
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Data was not evaluable in 2/30 participants from the cyclophosphamide and vaccine-only arm.
Outcome measures
| Measure |
Cyclophosphamide and Vaccine Only
n=28 Participants
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
n=30 Participants
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
|---|---|---|
|
HER-2/Neu-specific Immune Responses as Measured by Number of Participants With Positive for Delayed-type Hypersensitivity (DTH) Response
|
14 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Lab analysis could not be completed due to loss of funding, therefore data was not collected to assess this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Cyclophosphamide and Vaccine Only
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Cyclophosphamide, Vaccine and Trastuzumab
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyclophosphamide and Vaccine Only
n=30 participants at risk
Patients receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic GM-CSF-secreting breast cancer vaccine intradermally on day 0. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
cyclophosphamide: Given IV
|
Cyclophosphamide, Vaccine and Trastuzumab
n=30 participants at risk
Patients receive cyclophosphamide and the vaccine as in arm I and trastuzumab IV over 30-90 minutes on day -1. Courses repeat every 4-6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth vaccination at 6-8 months.
allogeneic GM-CSF-secreting breast cancer vaccine: Given intradermally
trastuzumab: Given IV
cyclophosphamide: Given IV
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema/swelling of vaccine sites
|
100.0%
30/30 • Number of events 82 • up to 6 months post-intervention
|
100.0%
30/30 • Number of events 102 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Pain/soreness/tenderness of vaccine sites
|
93.3%
28/30 • Number of events 81 • up to 6 months post-intervention
|
100.0%
30/30 • Number of events 82 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Pruritus of vaccine sites
|
100.0%
30/30 • Number of events 78 • up to 6 months post-intervention
|
100.0%
30/30 • Number of events 92 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Rash around vaccine sites
|
6.7%
2/30 • Number of events 3 • up to 6 months post-intervention
|
10.0%
3/30 • Number of events 3 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Blister at vaccine site
|
53.3%
16/30 • Number of events 28 • up to 6 months post-intervention
|
66.7%
20/30 • Number of events 41 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Ecchymosis at vaccine site
|
26.7%
8/30 • Number of events 10 • up to 6 months post-intervention
|
60.0%
18/30 • Number of events 24 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation at vaccine site
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
10.0%
3/30 • Number of events 3 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Warmth at vaccine site
|
53.3%
16/30 • Number of events 26 • up to 6 months post-intervention
|
56.7%
17/30 • Number of events 34 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Anorexia
|
43.3%
13/30 • Number of events 22 • up to 6 months post-intervention
|
33.3%
10/30 • Number of events 17 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Aphthus Ulcers
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 2 • up to 6 months post-intervention
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
15/30 • Number of events 32 • up to 6 months post-intervention
|
63.3%
19/30 • Number of events 33 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
General disorders
Chills
|
53.3%
16/30 • Number of events 29 • up to 6 months post-intervention
|
50.0%
15/30 • Number of events 27 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Dermatographism
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
0.00%
0/30 • up to 6 months post-intervention
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Dry throat
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
3/30 • Number of events 5 • up to 6 months post-intervention
|
6.7%
2/30 • Number of events 3 • up to 6 months post-intervention
|
|
General disorders
Fatigue
|
53.3%
16/30 • Number of events 34 • up to 6 months post-intervention
|
60.0%
18/30 • Number of events 32 • up to 6 months post-intervention
|
|
General disorders
Fever
|
36.7%
11/30 • Number of events 18 • up to 6 months post-intervention
|
36.7%
11/30 • Number of events 17 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
General disorders
Flu-like symptoms
|
6.7%
2/30 • Number of events 2 • up to 6 months post-intervention
|
6.7%
2/30 • Number of events 3 • up to 6 months post-intervention
|
|
Nervous system disorders
Headache
|
36.7%
11/30 • Number of events 21 • up to 6 months post-intervention
|
50.0%
15/30 • Number of events 18 • up to 6 months post-intervention
|
|
Cardiac disorders
Hypotension
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Infections and infestations
Infection, Herpes
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 2 • up to 6 months post-intervention
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Number of events 5 • up to 6 months post-intervention
|
20.0%
6/30 • Number of events 8 • up to 6 months post-intervention
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
30.0%
9/30 • Number of events 14 • up to 6 months post-intervention
|
63.3%
19/30 • Number of events 31 • up to 6 months post-intervention
|
|
General disorders
Malaise
|
6.7%
2/30 • Number of events 2 • up to 6 months post-intervention
|
10.0%
3/30 • Number of events 4 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.3%
16/30 • Number of events 41 • up to 6 months post-intervention
|
73.3%
22/30 • Number of events 37 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Nausea
|
40.0%
12/30 • Number of events 16 • up to 6 months post-intervention
|
26.7%
8/30 • Number of events 10 • up to 6 months post-intervention
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
3.3%
1/30 • Number of events 3 • up to 6 months post-intervention
|
0.00%
0/30 • up to 6 months post-intervention
|
|
Musculoskeletal and connective tissue disorders
Pain, bone
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 2 • up to 6 months post-intervention
|
|
Musculoskeletal and connective tissue disorders
Pain, hip/groin
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
6.7%
2/30 • Number of events 2 • up to 6 months post-intervention
|
10.0%
3/30 • Number of events 4 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.3%
7/30 • Number of events 10 • up to 6 months post-intervention
|
30.0%
9/30 • Number of events 12 • up to 6 months post-intervention
|
|
General disorders
Sweats
|
0.00%
0/30 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
3/30 • Number of events 4 • up to 6 months post-intervention
|
16.7%
5/30 • Number of events 5 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Vaccine flare
|
6.7%
2/30 • Number of events 2 • up to 6 months post-intervention
|
3.3%
1/30 • Number of events 1 • up to 6 months post-intervention
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 3 • up to 6 months post-intervention
|
6.7%
2/30 • Number of events 3 • up to 6 months post-intervention
|
|
Skin and subcutaneous tissue disorders
Hives
|
6.7%
2/30 • Number of events 9 • up to 6 months post-intervention
|
16.7%
5/30 • Number of events 5 • up to 6 months post-intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place