Trial Outcomes & Findings for Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer (NCT NCT00924287)

NCT ID: NCT00924287

Last Updated: 2015-10-28

Results Overview

Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 12 days
• Results posted on: 2015-10-28

Participant Flow

One participant was accrued to this study.

Participant milestones

Measure	Metastatic Cancer Cancer that has invaded other parts of the body
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Metastatic Cancer Cancer that has invaded other parts of the body
Overall Study Death	1

Baseline Characteristics

Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer

Baseline characteristics by cohort

Measure	Metastatic Cancer n=1 Participants Cancer that has invaded other parts of the body
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.0 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days

Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 days

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Outcome measures

Measure	Metastatic Cancer n=1 Participants Cancer that has invaded other parts of the body
Number of Participants With Adverse Events	1 Participants

SECONDARY outcome

Timeframe: 12 days

In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).

Outcome measures

Measure	Metastatic Cancer n=1 Participants Cancer that has invaded other parts of the body
Number of Participants With In Vivo Survival of Transfused Cells	1 Participants

Adverse Events

Metastatic Cancer

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metastatic Cancer n=1 participants at risk Cancer that has invaded other parts of the body
Blood and lymphatic system disorders Platelet count decreased	100.0% 1/1 • Number of events 1 • 12 days
Cardiac disorders Cardiopulmonary arrest	100.0% 1/1 • Number of events 2 • 12 days
Gastrointestinal disorders Lower gastrointestinal hemorrhage	100.0% 1/1 • Number of events 1 • 12 days
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • 12 days
Renal and urinary disorders Renal failure	100.0% 1/1 • Number of events 1 • 12 days

Other adverse events

Measure	Metastatic Cancer n=1 participants at risk Cancer that has invaded other parts of the body
Blood and lymphatic system disorders Hemoglobin decreased	100.0% 1/1 • Number of events 2 • 12 days
Blood and lymphatic system disorders Leukocyte count decreased	100.0% 1/1 • Number of events 1 • 12 days
Blood and lymphatic system disorders Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • 12 days
Blood and lymphatic system disorders Neutrophil count decreased	100.0% 1/1 • Number of events 1 • 12 days
Cardiac disorders Hypotension	100.0% 1/1 • Number of events 2 • 12 days
Blood and lymphatic system disorders Fibrinogen decreased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Activated partial thromboplastin time prolonged	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Acidosis	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Serum albumin decreased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Alanine aminotransferase increased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Aspartate aminotransferase increased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Bilirubin increased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Serum calcium decreased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Serum phosphate decreased	100.0% 1/1 • Number of events 2 • 12 days
Metabolism and nutrition disorders Serum potassium increased	100.0% 1/1 • Number of events 1 • 12 days
Metabolism and nutrition disorders Serum sodium increased	100.0% 1/1 • Number of events 1 • 12 days
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • Number of events 1 • 12 days
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Number of events 1 • 12 days
Renal and urinary disorders Low urine output	100.0% 1/1 • Number of events 1 • 12 days

Additional Information

Steven A. Rosenberg

National Cancer Institute, National Institutes of Health

Phone: 301-496-4164

Email: sar@mail.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place