Trial Outcomes & Findings for Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes (NCT NCT00393029)
NCT ID: NCT00393029
Last Updated: 2011-08-15
Results Overview
Response Evaluation Criteria In Solid Tumors (RECIST). See the protocol Link module for full criteria if desired.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
1-11 months
Results posted on
2011-08-15
Participant Flow
Expect to enroll 4-5 patients of each allowed histology up to a total of 82 patients. Approximately two years may be needed to accrue the maximum number of required patients.
Participant milestones
| Measure |
Metastatic Melanoma
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
|
Other Metastatic Cancers
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
|
Overall Study
COMPLETED
|
2
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Metastatic Melanoma
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
|
Other Metastatic Cancers
|
|---|---|---|
|
Overall Study
Not treated
|
0
|
1
|
Baseline Characteristics
Phase II Study of Metastatic Cancer That Overexpresses P53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes
Baseline characteristics by cohort
| Measure |
Metastatic Melanoma
n=2 Participants
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
|
Other Metastatic Cancers
n=10 Participants
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
44.5 years
STANDARD_DEVIATION 16.3 • n=99 Participants
|
45.4 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
44.95 years
STANDARD_DEVIATION 12.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
10 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1-11 monthsResponse Evaluation Criteria In Solid Tumors (RECIST). See the protocol Link module for full criteria if desired.
Outcome measures
| Measure |
Metastatic Melanoma & Other Metastatic Cancers
n=9 Participants
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
There are no statistical differences between the arms, therefore, they can be combined for this outcome measure.
|
Other Metastatic Cancers
|
|---|---|---|
|
Clinical Tumor Regression
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Metastatic Melanoma & Other Metastatic Cancers
n=2 Participants
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
There are no statistical differences between the arms, therefore, they can be combined for this outcome measure.
|
Other Metastatic Cancers
n=9 Participants
|
|---|---|---|
|
The Number of Participants With Adverse Events
|
2 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 3-12 monthsSurvival of TCR gene-engineered cells is defined as \>10% murine TCR positive cells.
Outcome measures
| Measure |
Metastatic Melanoma & Other Metastatic Cancers
n=2 Participants
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
There are no statistical differences between the arms, therefore, they can be combined for this outcome measure.
|
Other Metastatic Cancers
n=9 Participants
|
|---|---|---|
|
In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants
|
2 participants
|
9 participants
|
Adverse Events
Metastatic Melanoma
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Other Metastatic Cancers
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metastatic Melanoma
n=2 participants at risk
Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
|
Other Metastatic Cancers
n=9 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW-Hemoglobin decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
77.8%
7/9 • Number of events 9 • 15 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - Leukocyte count decreased
|
100.0%
2/2 • Number of events 2 • 15 months
|
100.0%
9/9 • Number of events 13 • 15 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW-Lymphocyte count decreased
|
100.0%
2/2 • Number of events 2 • 15 months
|
100.0%
9/9 • Number of events 15 • 15 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW-Neutrophil count decreased
|
100.0%
2/2 • Number of events 2 • 15 months
|
100.0%
9/9 • Number of events 11 • 15 months
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW -Platelet count decreased
|
100.0%
2/2 • Number of events 2 • 15 months
|
100.0%
9/9 • Number of events 10 • 15 months
|
|
Cardiac disorders
CARDIAC GENERAL - Hypotension
|
50.0%
1/2 • Number of events 1 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
COAGULATION - Activated partial thromboplastin time prolonged
|
50.0%
1/2 • Number of events 1 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS- Fatigue
|
50.0%
1/2 • Number of events 1 • 15 months
|
44.4%
4/9 • Number of events 4 • 15 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - Fever
|
50.0%
1/2 • Number of events 1 • 15 months
|
44.4%
4/9 • Number of events 5 • 15 months
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN-Rash desquamating
|
50.0%
1/2 • Number of events 1 • 15 months
|
55.6%
5/9 • Number of events 5 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL - Nausea
|
100.0%
2/2 • Number of events 2 • 15 months
|
66.7%
6/9 • Number of events 8 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL - Vomiting
|
50.0%
1/2 • Number of events 1 • 15 months
|
44.4%
4/9 • Number of events 5 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE/BLEEDING - Hemorrhage nasal
|
50.0%
1/2 • Number of events 1 • 15 months
|
0.00%
0/9 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE/BLEEDING-Respiratory tract hemorrhage
|
50.0%
1/2 • Number of events 1 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY-Serum albumin decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
44.4%
4/9 • Number of events 4 • 15 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY - Serum calcium decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY-Serum phosphate decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
22.2%
2/9 • Number of events 4 • 15 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY - Serum potassium decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Metabolism and nutrition disorders
METABOLIC/LABORATORY - Serum sodium decreased
|
50.0%
1/2 • Number of events 1 • 15 months
|
11.1%
1/9 • Number of events 3 • 15 months
|
|
Psychiatric disorders
NEUROLOGY - Confusion
|
50.0%
1/2 • Number of events 1 • 15 months
|
33.3%
3/9 • Number of events 3 • 15 months
|
|
Nervous system disorders
PAIN - Headache
|
50.0%
1/2 • Number of events 1 • 15 months
|
66.7%
6/9 • Number of events 7 • 15 months
|
|
Vascular disorders
VASCULAR-Capillary leak syndrome
|
50.0%
1/2 • Number of events 1 • 15 months
|
44.4%
4/9 • Number of events 5 • 15 months
|
|
Cardiac disorders
CARDIAC ARRHYTHMIA - Palpitations
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
General disorders
CONSTITUTIONAL SYMPTOMS-General symptom
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL- Anorexia
|
0.00%
0/2 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL-Diarrhea
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL- Ear, nose and throat examination abnormal
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL - Mucositis oral
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Blood and lymphatic system disorders
HEMORRHAGE/BLEEDING- Petechiae
|
0.00%
0/2 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Infections and infestations
INFECTION - Febrile neutropenia
|
0.00%
0/2 • 15 months
|
33.3%
3/9 • Number of events 3 • 15 months
|
|
Infections and infestations
INFECTION- Sepsis
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Infections and infestations
INFECTION -Vaginal infection
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Nervous system disorders
NEUROLOGY -Mini mental status examination abnormal
|
0.00%
0/2 • 15 months
|
22.2%
2/9 • Number of events 3 • 15 months
|
|
Nervous system disorders
NEUROLOGY- Anxiety
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
PAIN - Abdominal pain
|
0.00%
0/2 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
PAIN - Back pain
|
0.00%
0/2 • 15 months
|
44.4%
4/9 • Number of events 4 • 15 months
|
|
Reproductive system and breast disorders
PAIN - Breast pain
|
0.00%
0/2 • 15 months
|
22.2%
2/9 • Number of events 2 • 15 months
|
|
Musculoskeletal and connective tissue disorders
PAIN- Joint pain
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Musculoskeletal and connective tissue disorders
PAIN-Neck pain
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Nervous system disorders
PAIN -Neuralgia
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Gastrointestinal disorders
PAIN - Oral pain
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAIN-Tumor pain
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - Cough
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY- Dyspnea
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SECONDARY MALIGNANCY - Treatment related secondary malignancy
|
0.00%
0/2 • 15 months
|
11.1%
1/9 • Number of events 1 • 15 months
|
Additional Information
Steven Rosenberg, M.D., Ph.D.
National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place