Trial · NCT00393029

Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes

NCT00393029, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes. Trials, record NCT00393029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00393029

On this page

Trial

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

Title: Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes
NCT number: NCT00393029
Status: Completed
Phases: Phase 2
Enrollment: 12 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Anti-p53 TCR-Gene
Interventions: anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes, aldesleukin, filgrastim, cyclophosphamide, fludarabine phosphate
First posted: 2006-10-26
Last updated: 2011-08-15
Results first posted: 2011-08-05

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Clinical Tumor Regression	1-11 months	Response Evaluation Criteria In Solid Tumors (RECIST). See the protocol Link module for full criteria if desired.
Primary	The Number of Participants With Adverse Events	events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.	Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module.
Secondary	In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants	3-12 months	Survival of TCR gene-engineered cells is defined as \>10% murine TCR positive cells.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Clinical Tumor Regression	1-11 months	Participants	NUMBER
PRIMARY	The Number of Participants With Adverse Events	events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.	participants	NUMBER
SECONDARY	In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants	3-12 months	participants	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Units
Clinical Tumor Regression	Metastatic Melanoma & Other Metastatic Cancers	1	Participants
The Number of Participants With Adverse Events	Metastatic Melanoma	2	participants
The Number of Participants With Adverse Events	Other Metastatic Cancers	9	participants
In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants	Metastatic Melanoma	2	participants
In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants	Other Metastatic Cancers	9	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Metastatic Melanoma	2
Overall Study	STARTED	Other Metastatic Cancers	10
Overall Study	COMPLETED	Metastatic Melanoma	2
Overall Study	COMPLETED	Other Metastatic Cancers	9
Overall Study	NOT COMPLETED	Metastatic Melanoma	0
Overall Study	NOT COMPLETED	Other Metastatic Cancers	1

Source ClinicalTrials.gov

Adverse events90

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	BLOOD/BONE MARROW-Hemoglobin decreased	Blood and lymphatic system disorders	Metastatic Melanoma	1	2	1
other	BLOOD/BONE MARROW-Hemoglobin decreased	Blood and lymphatic system disorders	Other Metastatic Cancers	7	9	9
other	BLOOD/BONE MARROW - Leukocyte count decreased	Blood and lymphatic system disorders	Metastatic Melanoma	2	2	2
other	BLOOD/BONE MARROW - Leukocyte count decreased	Blood and lymphatic system disorders	Other Metastatic Cancers	9	9	13
other	BLOOD/BONE MARROW-Lymphocyte count decreased	Blood and lymphatic system disorders	Metastatic Melanoma	2	2	2
other	BLOOD/BONE MARROW-Lymphocyte count decreased	Blood and lymphatic system disorders	Other Metastatic Cancers	9	9	15
other	BLOOD/BONE MARROW-Neutrophil count decreased	Blood and lymphatic system disorders	Metastatic Melanoma	2	2	2
other	BLOOD/BONE MARROW-Neutrophil count decreased	Blood and lymphatic system disorders	Other Metastatic Cancers	9	9	11
other	BLOOD/BONE MARROW -Platelet count decreased	Blood and lymphatic system disorders	Metastatic Melanoma	2	2	2
other	BLOOD/BONE MARROW -Platelet count decreased	Blood and lymphatic system disorders	Other Metastatic Cancers	9	9	10

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metastatic Melanoma
Total, all-cause mortality	Other Metastatic Cancers
Total, other adverse events	Metastatic Melanoma	2	2
Total, other adverse events	Other Metastatic Cancers	9	9
Total, serious adverse events	Metastatic Melanoma	0	2
Total, serious adverse events	Other Metastatic Cancers	0	9

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
7516411	BACKGROUND	PubMed
8022805	BACKGROUND	PubMed
8170938	BACKGROUND	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 comparisons3

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

Comparison	Source
Metastatic Melanoma vs Other Metastatic Cancers: The Number of Participants With Adverse Events	Trial comparisons
Metastatic Melanoma vs Other Metastatic Cancers: In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants	Trial comparisons
Metastatic Melanoma vs Other Metastatic Cancers: serious adverse events	Trial comparisons

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/NCT00393029

GET https://conductscience.org/api/trials/v1/NCT00393029/events?page=2

API reference For AI assistants