Trial Outcomes & Findings for Phase II Study of Aldesleukin (IL-2) Following the Administration of Zanolimumab (Anti-CD4mAb) in Metastatic Melanoma and Metastatic Renal Cancer (NCT NCT01160445)
NCT ID: NCT01160445
Last Updated: 2015-10-28
Results Overview
Tumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
HD IL-2 + Zanolimumab - Melanoma
Patients with metastatic melanoma
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
HD IL-2 + Zanolimumab - Renal Cell
Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
2
|
|
Overall Study
COMPLETED
|
7
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Aldesleukin (IL-2) Following the Administration of Zanolimumab (Anti-CD4mAb) in Metastatic Melanoma and Metastatic Renal Cancer
Baseline characteristics by cohort
| Measure |
HD IL-2 + Zanolimumab - Melanoma
n=7 Participants
Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
HD IL-2 + Zanolimumab - Renal Cell
n=2 Participants
Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
Total
n=9 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
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
61.0 years
STANDARD_DEVIATION 5.7 • n=107 Participants
|
50.7 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 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
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 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
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 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
|
7 participants
n=99 Participants
|
2 participants
n=107 Participants
|
9 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTumor regression was assessed by the Response Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% in the sum of the longest diameter (LD) recorded since the treatment started. Stable disease (SD) is neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the smallest sum LD.
Outcome measures
| Measure |
HD IL-2 + Zanolimumab - Melanoma
n=7 Participants
Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
HD IL-2 + Zanolimumab - Renal Cell
n=2 Participants
Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
|---|---|---|
|
The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.
Partial Response
|
0 Participants
|
0 Participants
|
|
The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.
Stable Disease
|
0 Participants
|
0 Participants
|
|
The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.
Complete Response
|
0 Participants
|
0 Participants
|
|
The Ability of a Combination of Aldesleukin (IL-2) and Zanolimumab (Anti-CD4 mAb) Administration to Mediate Tumor Regression in Patients With Metastatic Melanoma and Metastatic Kidney Cancer.
Progressive Disease
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 10 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
HD IL-2 + Zanolimumab - Melanoma
n=7 Participants
Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
HD IL-2 + Zanolimumab - Renal Cell
n=2 Participants
Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
|---|---|---|
|
Toxicity of Zanolimumab and IL-2 Treatment Regimen
|
7 Participants
|
2 Participants
|
Adverse Events
HD IL-2 + Zanolimumab - Melanoma
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
HD IL-2 + Zanolimumab - Renal Cell
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HD IL-2 + Zanolimumab - Melanoma
n=7 participants at risk
Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
HD IL-2 + Zanolimumab - Renal Cell
n=2 participants at risk
Patients with metastatic renal cancer
Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
7/7 • Number of events 14
|
100.0%
2/2 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
57.1%
4/7 • Number of events 7
|
50.0%
1/2 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
7/7 • Number of events 21
|
100.0%
2/2 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
57.1%
4/7 • Number of events 6
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
85.7%
6/7 • Number of events 9
|
50.0%
1/2 • Number of events 3
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
28.6%
2/7 • Number of events 3
|
0.00%
0/2
|
|
Cardiac disorders
Hypotension
|
71.4%
5/7 • Number of events 8
|
100.0%
2/2 • Number of events 3
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
100.0%
7/7 • Number of events 14
|
100.0%
2/2 • Number of events 5
|
|
General disorders
Fatigue
|
100.0%
7/7 • Number of events 17
|
100.0%
2/2 • Number of events 8
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
71.4%
5/7 • Number of events 12
|
100.0%
2/2 • Number of events 4
|
|
General disorders
Insomnia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Rigors/chills
|
85.7%
6/7 • Number of events 6
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Sweating (diaphoresis)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
100.0%
7/7 • Number of events 7
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Hemorroids
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 7
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 3
|
50.0%
1/2 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC
|
28.6%
2/7 • Number of events 5
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Edema: limb
|
42.9%
3/7 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
57.1%
4/7 • Number of events 12
|
100.0%
2/2 • Number of events 7
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
85.7%
6/7 • Number of events 9
|
100.0%
2/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
100.0%
7/7 • Number of events 15
|
100.0%
2/2 • Number of events 3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
57.1%
4/7 • Number of events 7
|
100.0%
2/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
42.9%
3/7 • Number of events 4
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
14.3%
1/7 • Number of events 1
|
100.0%
2/2 • Number of events 3
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
100.0%
7/7 • Number of events 12
|
50.0%
1/2 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
57.1%
4/7 • Number of events 7
|
100.0%
2/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
28.6%
2/7 • Number of events 4
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
85.7%
6/7 • Number of events 15
|
100.0%
2/2 • Number of events 3
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
57.1%
4/7 • Number of events 5
|
50.0%
1/2 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
28.6%
2/7 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
28.6%
2/7 • Number of events 3
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
28.6%
2/7 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
42.9%
3/7 • Number of events 5
|
100.0%
2/2 • Number of events 4
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
57.1%
4/7 • Number of events 7
|
0.00%
0/2
|
|
Nervous system disorders
Cognitive disturbance
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Confusion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Dizziness
|
42.9%
3/7 • Number of events 3
|
0.00%
0/2
|
|
Nervous system disorders
Mental status
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Pain
|
71.4%
5/7 • Number of events 9
|
100.0%
2/2 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
71.4%
5/7 • Number of events 6
|
100.0%
2/2 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Vascular disorders
Acute vascular leak syndrome
|
71.4%
5/7 • Number of events 8
|
50.0%
1/2 • Number of events 1
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/7
|
50.0%
1/2 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/7
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify, upset stomach/gr 1)
|
14.3%
1/7 • Number of events 1
|
0.00%
0/2
|
Additional Information
Dr. Steven Rosenberg
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