Trial Outcomes & Findings for Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer (NCT NCT00880464)

Last Updated: 2022-04-01

Results Overview

Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter. Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF). Then, the cells washed extensively and irradiated with 10,000 cGy. Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination. Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production. For stage II-III patients, the minimal dose was 1 x 10\^5 cells and the maximal dose was 4 x 10\^6 cells. For metastatic patients, the minimal dose was 1 x 10\^5 cells and the maximal dose was 1 x 10\^7 cells.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

40 Months

Results posted on

2022-04-01

Participant Flow

January 2006 through May 2008

Participant milestones

Participant milestones
Measure	Stage II-III Breast Cancer Cohort Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metastatic Breast Cancer Cohort n=7 Participants Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Age, Continuous	51.5 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	7 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
Clinical Stage T3, N1	3 Participants n=5 Participants
Clinical Stage T4, N0, M1	1 Participants n=5 Participants
Clinical Stage T4, N1	2 Participants n=5 Participants
Clinical Stage T4, N2	1 Participants n=5 Participants
Hormone Receptor Status Positive	5 Participants n=5 Participants
Hormone Receptor Status Negative	2 Participants n=5 Participants
Human Epidermal Growth Factor Receptor 2 Status Positive	1 Participants n=5 Participants
Human Epidermal Growth Factor Receptor 2 Status Negative	6 Participants n=5 Participants
Triple Negative Positive	2 Participants n=5 Participants
Triple Negative Negative	5 Participants n=5 Participants
Type of Surgery Mastectomy	6 Participants n=5 Participants
Type of Surgery Lumpectomy	1 Participants n=5 Participants
Pathologic Response to Neoadjuvant Therapy Partial Response	6 Participants n=5 Participants
Pathologic Response to Neoadjuvant Therapy Not Available	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 40 Months

Population: Vaccinations prepared for "enrolled for vaccine administration" population.

Outcome measures

Outcome measures
Measure	Vaccine n=7 Participants Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Minimum Number of Vaccine Doses Created Using Participant Tumor Sample	6 doses

PRIMARY outcome

Timeframe: Up to 58 Months

Population: Analysis population for adverse events is "Treated" population.

Number of participants with grade 3 or higher adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Vaccine n=7 Participants Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Number of Participants With Grade 3 or Higher Adverse Events Grade 3	1 Participants
Number of Participants With Grade 3 or Higher Adverse Events Grade 4	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events Grade 5	0 Participants

SECONDARY outcome

Timeframe: Up to 14 Years

Population: Clinical outcomes assessed for the "treated" population.

Participants followed for survival status. Participants who were alive were noted as such as late as December 2020.

Outcome measures

Outcome measures
Measure	Vaccine n=7 Participants Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Median Follow-up Time by Survival Status Alive	9.88 years Interval 9.76 to 9.99
Median Follow-up Time by Survival Status Dead	6.24 years Interval 1.16 to 8.49

Adverse Events

Vaccine

Serious events: 1 serious events

Other events: 7 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Vaccine n=7 participants at risk Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Other adverse events

Other adverse events
Measure	Vaccine n=7 participants at risk Biological/Vaccine: Autologous, Lethally Irradiated Breast Cancer Cells Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out Autologous, Lethally Irradiated Breast Cancer Cells: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Immune system disorders Allergic Reaction	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders General disorders and administration site conditions - Other, specify	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 2/7 • Number of events 3 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Fat atrophy	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	100.0% 7/7 • Number of events 17 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fever	28.6% 2/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Headache	28.6% 2/7 • Number of events 3 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Vascular disorders - Other, specify	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hot Flashes	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Upper respiratory infection	28.6% 2/7 • Number of events 3 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthralgia	57.1% 4/7 • Number of events 7 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Memory Impairment	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Myalgia	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	28.6% 2/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	14.3% 1/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Nervous system disorders - Other, specify	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral sensory neuropathy	42.9% 3/7 • Number of events 3 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Pain	28.6% 2/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	14.3% 1/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Number of events 1 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	28.6% 2/7 • Number of events 2 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	14.3% 1/7 • Number of events 3 • Up to 14 Years Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Beth Overmoyer

Mass General Brigham

Phone: 617 632 3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place