Trial Outcomes & Findings for Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer (NCT NCT00399529)
NCT ID: NCT00399529
Last Updated: 2020-04-22
Results Overview
Safety is measured as the number of patients that experienced adverse events related to study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From first dose through 30 days after last dose of study drug, up to 9 months
Results posted on
2020-04-22
Participant Flow
Participant milestones
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
Allogeneic granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting breast cancer vaccine: the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide (Cy): 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
Allogeneic granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting breast cancer vaccine: the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide (Cy): 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Overall Study
Off Study Prior to Treatment
|
2
|
Baseline Characteristics
Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for the Treatment of HER-2/Neu-Overexpressing Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=22 Participants
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Age, Continuous
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 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
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose through 30 days after last dose of study drug, up to 9 monthsSafety is measured as the number of patients that experienced adverse events related to study drug.
Outcome measures
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=20 Participants
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Number of Participants With Adverse Events
Nausea
|
1 Participants
|
|
Number of Participants With Adverse Events
Fatigue
|
8 Participants
|
|
Number of Participants With Adverse Events
Urticaria
|
7 Participants
|
|
Number of Participants With Adverse Events
Pruritus
|
6 Participants
|
|
Number of Participants With Adverse Events
Fever
|
5 Participants
|
|
Number of Participants With Adverse Events
Flu-like symptoms
|
4 Participants
|
|
Number of Participants With Adverse Events
Lymphadenopathy
|
4 Participants
|
|
Number of Participants With Adverse Events
Abdominal pain
|
3 Participants
|
|
Number of Participants With Adverse Events
Rash
|
3 Participants
|
|
Number of Participants With Adverse Events
Malaise
|
3 Participants
|
|
Number of Participants With Adverse Events
Chills
|
3 Participants
|
|
Number of Participants With Adverse Events
Dizziness
|
2 Participants
|
|
Number of Participants With Adverse Events
Anorexia
|
1 Participants
|
|
Number of Participants With Adverse Events
Erythema
|
1 Participants
|
|
Number of Participants With Adverse Events
Headache
|
1 Participants
|
|
Number of Participants With Adverse Events
Arm pain
|
1 Participants
|
|
Number of Participants With Adverse Events
Cancer site pain
|
1 Participants
|
|
Number of Participants With Adverse Events
Leg pain
|
1 Participants
|
|
Number of Participants With Adverse Events
Groin tightness
|
1 Participants
|
|
Number of Participants With Adverse Events
Erythema at vaccine sites
|
20 Participants
|
|
Number of Participants With Adverse Events
Pruritus at vaccine sites
|
20 Participants
|
|
Number of Participants With Adverse Events
Induration at vaccine sites
|
20 Participants
|
|
Number of Participants With Adverse Events
Pain at vaccine sties
|
17 Participants
|
|
Number of Participants With Adverse Events
Rash at vaccine sites
|
7 Participants
|
|
Number of Participants With Adverse Events
Blister at vaccine sites
|
5 Participants
|
|
Number of Participants With Adverse Events
Hyperpigmentation at vaccine sites
|
4 Participants
|
|
Number of Participants With Adverse Events
Bruising at vaccine sites
|
3 Participants
|
|
Number of Participants With Adverse Events
Edema at vaccine sites
|
2 Participants
|
|
Number of Participants With Adverse Events
Vaccine site flare
|
2 Participants
|
PRIMARY outcome
Timeframe: At 6 and 12 months from start of treatmentClinical benefit is defined as the proportion of patients achieving complete response, partial response, or stable disease by RECIST. Complete response (CR) is defined as total disappearance of all clinical evidence of reversible disease. A partial response (PR) is defined as a \>=30% reduction in tumor target lesions. Stable disease (SD) is defined as disease status that fails to qualify as as a response (CR or PR) or progressive disease (increase of at least 20% in tumor target lesions).
Outcome measures
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=20 Participants
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Number of Participants With Clinical Benefit
Clinical Benefit at 6 months
|
11 Participants
|
|
Number of Participants With Clinical Benefit
Clinical Benefit at 12 months
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 days after each vaccine, up to 9 monthsThe number of participants with a Delayed Type Hypersensitivity (DTH) response was measured as an indicator of immune response. Participants were considered to have a DTH response if they had increased induration (\>5mm from baseline) at the site of injection 2-3 days after intradermal injection with human epidermal growth factor receptor 2 (HER-2) peptides. This peptide injection was given 28 days after each dose of vaccine.
Outcome measures
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=20 Participants
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Number of Participants With Delayed Type Hypersensitivity (Immunological Response)
|
7 Participants
|
Adverse Events
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=20 participants at risk
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
Other adverse events
| Measure |
Allo GM-CSF-secreting Vaccine, Trastuzumab, Cyclophosphamide
n=20 participants at risk
Allogeneic GM-CSF-secreting breast cancer vaccine : the vaccine containing a mixture of two GM-CSF-secreting allogeneic breast cancer cell lines (two parts 2T47D-V and one part 3SKBR3-7 mixed in a fixed dose of 5 X 10\^8 cells for each patient and each vaccination cycle) given intradermally every 4-6 weeks for 3 cycles and then a 4th dose given 6-8 months after beginning the study.
Cyclophosphamide : 300 mg/m\^2 given intravenously every 4-6 weeks for 3 cycles and then once 6-8 months after beginning the study
Trastuzumab : An initial loading dose of 4 mg/kg for participants beginning treatment with Trastuzumab, otherwise 2 mg/kg given every week intravenously
|
|---|---|
|
General disorders
Fatigue
|
40.0%
8/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
35.0%
7/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.0%
6/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Fever
|
25.0%
5/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Flu-like symptoms
|
20.0%
4/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
20.0%
4/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.0%
3/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
3/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Malaise
|
15.0%
3/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Chills
|
15.0%
3/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Arm Pain
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Cancer Site Pain
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Erythema at Vaccine Sites
|
100.0%
20/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Pruritus at Vaccine Sites
|
100.0%
20/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Pain at Vaccine Sites
|
85.0%
17/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Rash at Vaccine Sites
|
35.0%
7/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Blister at Vaccine Sites
|
25.0%
5/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Hyperpigmentation at Vaccine Sites
|
20.0%
4/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Bruising at Vaccine Sites
|
15.0%
3/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Edema at Vaccine Sites
|
10.0%
2/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Vaccine Site Flares
|
10.0%
2/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
Musculoskeletal and connective tissue disorders
Groin Tightness
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
|
General disorders
Induration at Vaccine Sites
|
5.0%
1/20 • Adverse Events were collected from first dose through 30 days after last dose of study drugs, up to 9 months.
|
Additional Information
Dr. Leisha Emens
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 412-623-3239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place