Trial Outcomes & Findings for Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma (NCT NCT00096382)
NCT ID: NCT00096382
Last Updated: 2015-10-28
Results Overview
Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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 taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.
Results posted on
2015-10-28
Participant Flow
Of the 34 participants who were enrolled, 8 patients were not assigned to treatment since their TIL did not grow. Of the 26 assigned to treatment, 1 patient was not actually treated therefore only 25 patients were evaluable.
Participant milestones
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
3
|
|
Overall Study
COMPLETED
|
21
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
Overall Study
Not treated
|
1
|
0
|
|
Overall Study
Death during treatment
|
1
|
0
|
Baseline Characteristics
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
n=23 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
n=3 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
44.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
3 participants
n=7 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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 taking as reference the baseline sum LD.
Outcome measures
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
n=23 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
n=3 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
Clinical Tumor Regression
Complete Response
|
1 Participants
|
1 Participants
|
|
Clinical Tumor Regression
Partial Response
|
9 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 4 yearsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
n=23 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
n=3 Participants
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
Safety
|
23 Participants
|
3 Participants
|
Adverse Events
TBI 200cGy + TIL +HD IL-2, Prior IL-2
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
n=22 participants at risk
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
n=3 participants at risk
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
General disorders
Fatigue
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dehydration
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Infection
|
13.6%
3/22 • Number of events 3
|
0.00%
0/3
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Thrombosis
|
0.00%
0/22
|
33.3%
1/3 • Number of events 1
|
Other adverse events
| Measure |
TBI 200cGy + TIL +HD IL-2, Prior IL-2
n=22 participants at risk
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
TBI 200cGy + TIL +HD IL-2, No Prior IL-2
n=3 participants at risk
Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.
Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.3%
6/22 • Number of events 6
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
77.3%
17/22 • Number of events 17
|
33.3%
1/3 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
95.5%
21/22 • Number of events 21
|
100.0%
3/3 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelet
|
72.7%
16/22 • Number of events 16
|
100.0%
3/3 • Number of events 3
|
|
Cardiac disorders
Ventricular arrhythmia
|
4.5%
1/22 • Number of events 1
|
100.0%
3/3 • Number of events 3
|
|
Cardiac disorders
Supraventricular & nodal arrhythmia
|
4.5%
1/22 • Number of events 1
|
100.0%
3/3 • Number of events 3
|
|
Cardiac disorders
Vasovagal episode
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Cardiac disorders
Hypertension
|
4.5%
1/22 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
36.4%
8/22 • Number of events 8
|
0.00%
0/3
|
|
General disorders
Rigors/Chills
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
18.2%
4/22 • Number of events 4
|
0.00%
0/3
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
13.6%
3/22 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Insomnia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Weight loss
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
9.1%
2/22 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
4/22 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Distention, bloating, abdominal
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Heartburn/Dyspepsia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • Number of events 3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Infections and infestations
Febrile Neutropenia
|
40.9%
9/22 • Number of events 9
|
100.0%
3/3 • Number of events 3
|
|
Infections and infestations
Infection
|
22.7%
5/22 • Number of events 5
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
40.9%
9/22 • Number of events 9
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
ALT/SGPT (serum glutamic pyruvic transaminase)
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
AST/SGOT (serum glutamic oxaloacetic transaminase)
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
9.1%
2/22 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
18.2%
4/22 • Number of events 4
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
13.6%
3/22 • Number of events 3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
9.1%
2/22 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
4.5%
1/22 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
13.6%
3/22 • Number of events 3
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia) increased
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
13.6%
3/22 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Metabolism and nutrition disorders
Uric acid
|
13.6%
3/22 • Number of events 3
|
0.00%
0/3
|
|
Nervous system disorders
Apnea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Leak, Cerebrospinal fluid (CSF)
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Confusion
|
13.6%
3/22 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Syncope (fainting)
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Tremor
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
59.1%
13/22 • Number of events 13
|
66.7%
2/3 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
22.7%
5/22 • Number of events 5
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
4.5%
1/22 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Renal and urinary disorders
Incontinence, urinary
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Eye disorders
Retinopathy
|
0.00%
0/22
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Mood alteration
|
0.00%
0/22
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Pain
|
50.0%
11/22 • Number of events 11
|
0.00%
0/3
|
|
Vascular disorders
Acute vascular leak syndrome
|
4.5%
1/22 • Number of events 1
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
22/22 • Number of events 22
|
100.0%
3/3 • Number of events 3
|
|
Blood and lymphatic system disorders
PTT (partial thromboplastin time)
|
13.6%
3/22 • Number of events 3
|
100.0%
3/3 • Number of events 3
|
Additional Information
Steven A. Rosenberg, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-4164
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place