Trial · NCT00089778

Vaccine Treatment of Kidney Cancer

NCT00089778, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2012-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Treatment of Kidney Cancer. Trials, record NCT00089778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00089778

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Trial

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

Title: Vaccine Treatment of Kidney Cancer
NCT number: NCT00089778
Status: Terminated
Phases: Phase 2
Enrollment: 11 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Kidney Cancer
Interventions: 117-126:Fibroblast growth factor 5 (FGF-5), Fibroblast growth factor 5 (FGF-5):172-176/217-220, IL-2
First posted: 2004-08-13
Last updated: 2017-08-01
Results first posted: 2012-10-11

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Response	3 years and 9 months	Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Primary	Count of Participants With Adverse Events	47 months	Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.
Primary	Immunologic Response to Peptide Vaccination Pre and Post Vaccination	24 hours	FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.

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	Response	3 years and 9 months	Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Count of Participants With Adverse Events	47 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Immunologic Response to Peptide Vaccination Pre and Post Vaccination	24 hours	1 uM A3 culture vs tranfectant means Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against \[with\] target cells into which the FGF-5 target gene was inserted \[transfected with\] and the release of interferon is measured to detect immune recognition.Documentation was only available for the 4 patients.	pg/ml/24 hrs	NUMBER

Source ClinicalTrials.gov

Results by group47

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

Outcome	Group	Category	Value	Units
Response	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	Complete response	0	Participants
Response	Grp B - Measurable Metastatic Disease That Require Aldesleukin	Complete response	0	Participants
Response	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	Partial Response	0	Participants
Response	Grp B - Measurable Metastatic Disease That Require Aldesleukin	Partial Response	0	Participants
Response	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	Progressive disease	2	Participants
Response	Grp B - Measurable Metastatic Disease That Require Aldesleukin	Progressive disease	1	Participants
Response	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	Stable disease	0	Participants
Response	Grp B - Measurable Metastatic Disease That Require Aldesleukin	Stable disease	0	Participants
Response	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	Not evaluable	0	Participants
Response	Grp B - Measurable Metastatic Disease That Require Aldesleukin	Not evaluable	0	Participants

1 to 10 of 47Source ClinicalTrials.gov

See all 47 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	2
Overall Study	STARTED	Grp B - Measurable Metastatic Disease That Require Aldesleukin	1
Overall Study	STARTED	Grp C - High-risk Loco-regional Disease	8
Overall Study	COMPLETED	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	2
Overall Study	COMPLETED	Grp B - Measurable Metastatic Disease That Require Aldesleukin	1
Overall Study	COMPLETED	Grp C - High-risk Loco-regional Disease	7
Overall Study	NOT COMPLETED	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	0
Overall Study	NOT COMPLETED	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0
Overall Study	NOT COMPLETED	Grp C - High-risk Loco-regional Disease	1

Source ClinicalTrials.gov

Adverse events117

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	Events
other	Hemoglobin decreased	Investigations	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	1	2	1
other	Hemoglobin decreased	Investigations	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0	1	0
other	Hemoglobin decreased	Investigations	Grp C - High-risk Loco-regional Disease	0	8	0
other	Activated partial thromboplastin time prolonged (aPTT)	Investigations	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	1	2	1
other	Activated partial thromboplastin time prolonged (aPTT)	Investigations	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0	1	0
other	Activated partial thromboplastin time prolonged (aPTT)	Investigations	Grp C - High-risk Loco-regional Disease	0	8	0
other	Fatigue	General disorders	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	1	2	2
other	Fatigue	General disorders	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0	1	0
other	Fatigue	General disorders	Grp C - High-risk Loco-regional Disease	1	8	1
other	Injection site reaction	Injury, poisoning and procedural complications	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	2	2	5

1 to 10 of 117Source ClinicalTrials.gov

See all 117 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	0	2
Total, all-cause mortality	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0	1
Total, all-cause mortality	Grp C - High-risk Loco-regional Disease	0	8
Total, other adverse events	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	2	2
Total, other adverse events	Grp B - Measurable Metastatic Disease That Require Aldesleukin	1	1
Total, other adverse events	Grp C - High-risk Loco-regional Disease	8	8
Total, serious adverse events	Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)	1	2
Total, serious adverse events	Grp B - Measurable Metastatic Disease That Require Aldesleukin	0	1
Total, serious adverse events	Grp C - High-risk Loco-regional Disease	1	8

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
1840703	BACKGROUND

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.

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