Trial · NCT00317603

Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients

NCT00317603, Phase 1, Completed, Dana-Farber Cancer Institute; results first posted 2021-10-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients. Trials, record NCT00317603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00317603

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
NCT number: NCT00317603
Status: Completed
Phases: Phase 1
Enrollment: 15 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Breast Cancer
Interventions: Autologous, Lethally Irradiated Breast Cancer Cells
First posted: 2006-04-25
Last updated: 2022-04-01
Results first posted: 2021-10-14

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Minimum Number of Vaccine Doses Created Using Participant Tumor Sample	Vaccine doses created and banked soon after registration, up to 8 days.	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. The minimal dose was 1 x 10\^5 cells and the maximal dose was 1 x 10\^7 cells.
Secondary	Number of Participants With Grade 3 or Higher Adverse Events	Up to 58 Months	Number of participants with grade 3 or higher adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Secondary	Number of Participants With RECIST Criteria Responses	Up to 14 Years	Clinical outcomes as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Minimum Number of Vaccine Doses Created Using Participant Tumor Sample	Vaccine doses created and banked soon after registration, up to 8 days.	Vaccinations prepared for enrolled for vaccine administration population.	doses	NUMBER
SECONDARY	Number of Participants With Grade 3 or Higher Adverse Events	Up to 58 Months	Analysis population for adverse events is Treated population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With RECIST Criteria Responses	Up to 14 Years	Clinical outcomes assessed for the treated population.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Minimum Number of Vaccine Doses Created Using Participant Tumor Sample	Vaccine		6	doses
Number of Participants With Grade 3 or Higher Adverse Events	Vaccine	Grade 3	0	Participants
Number of Participants With Grade 3 or Higher Adverse Events	Vaccine	Grade 4	0	Participants
Number of Participants With Grade 3 or Higher Adverse Events	Vaccine	Grade 5	0	Participants
Number of Participants With RECIST Criteria Responses	Vaccine	Progressive Disease within 2 months	8	Participants
Number of Participants With RECIST Criteria Responses	Vaccine	Stable Disease with progression at 4 months	2	Participants
Number of Participants With RECIST Criteria Responses	Vaccine	Stable Disease with progression at 13 months	1	Participants
Number of Participants With RECIST Criteria Responses	Vaccine	No Evidence of Disease > 12 years	1	Participants

Source ClinicalTrials.gov

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vaccine	15
Overall Study	Treated	Vaccine	12
Overall Study	COMPLETED	Vaccine	12
Overall Study	NOT COMPLETED	Vaccine	3

Source ClinicalTrials.gov

Adverse events71

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hemoglobin	Blood and lymphatic system disorders	Vaccine	8	12
other	Palpitations	Cardiac disorders	Vaccine	1	12
other	Ventricular tachycardia	Cardiac disorders	Vaccine	1	12
other	Constipation	Gastrointestinal disorders	Vaccine	3	12
other	Diarrhea w/o prior colostomy	Gastrointestinal disorders	Vaccine	4	12
other	Distention/bloating, abdominal	Gastrointestinal disorders	Vaccine	1	12
other	Gastritis	Gastrointestinal disorders	Vaccine	1	12
other	Dyspepsia	Gastrointestinal disorders	Vaccine	1	12
other	Nausea	Gastrointestinal disorders	Vaccine	10	12
other	Vomiting	Gastrointestinal disorders	Vaccine	7	12

1 to 10 of 71Source ClinicalTrials.gov

See all 71 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vaccine	12	12
Total, other adverse events	Vaccine	12	12
Total, serious adverse events	Vaccine	3	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35482127	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00317603

GET https://conductscience.org/api/trials/v1/NCT00317603/events?page=2

API reference For AI assistants