Trial Outcomes & Findings for Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney (NCT NCT00853021)
NCT ID: NCT00853021
Last Updated: 2019-06-05
Results Overview
Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
From baseline (day -14) to disease progression (reported at 2 years)
Results posted on
2019-06-05
Participant Flow
Participant milestones
| Measure |
Bevacizumab and Aldesleukin
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Bevacizumab and Aldesleukin
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney
Baseline characteristics by cohort
| Measure |
Bevacizumab and Aldesleukin
n=26 Participants
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 6.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From baseline (day -14) to disease progression (reported at 2 years)Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.
Outcome measures
| Measure |
Bevacizumab and Aldesleukin
n=26 Participants
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Progression Free Survival
|
9.6 months
Interval 4.1 to 16.9
|
SECONDARY outcome
Timeframe: 4 weeks after end of treatmentObjective response rate to be assigned a status of PR or CR per RECIST criteria, with Complete Response (CR) referring to the disappearance of all target lesions, Partial Response (PR) referring to at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
Outcome measures
| Measure |
Bevacizumab and Aldesleukin
n=26 Participants
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Objective Response Rate (Complete and Partial Response)
|
15 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment to 30 days after treatmentToxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills
Outcome measures
| Measure |
Bevacizumab and Aldesleukin
n=26 Participants
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Percentage of Patients With Constitutional Adverse Events
|
42 percentage of patients
|
SECONDARY outcome
Timeframe: From start of treatment to 30 days after treatmentToxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia
Outcome measures
| Measure |
Bevacizumab and Aldesleukin
n=26 Participants
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Percentage of Patients With Neutropenia
|
12 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), Beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (day -14), beginning and end of cycle 1 (day 1, 57)Peripheral blood mononuclear cells (PBMC) and plasma were separated by centrifugation. Targeted cells were isolated by a magnetic labeling system. Total RNA was isolated and then amplified by (Polymerase Chain Reactions) PCR to measure levels of the immune parameter.
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab and Aldesleukin
Serious events: 9 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab and Aldesleukin
n=26 participants at risk
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
3.8%
1/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Ascites
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Cardiac disorders
Heart failure
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Psychiatric disorders
Confusion
|
3.8%
1/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Hepatobiliary disorders
Hepatic failure
|
3.8%
1/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Infections and infestations
Infection without neutropenia
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
3.8%
1/26 • Number of events 1 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
Other adverse events
| Measure |
Bevacizumab and Aldesleukin
n=26 participants at risk
aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
23.1%
6/26 • Number of events 11 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
50.0%
13/26 • Number of events 27 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Anorexia
|
80.8%
21/26 • Number of events 49 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint pain)
|
26.9%
7/26 • Number of events 15 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
2/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Constipation
|
30.8%
8/26 • Number of events 13 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
10/26 • Number of events 14 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Investigations
Creatinine Increased
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Dehydration
|
19.2%
5/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Diarrhea
|
69.2%
18/26 • Number of events 32 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.8%
8/26 • Number of events 9 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
4/26 • Number of events 6 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
42.3%
11/26 • Number of events 19 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Edema
|
7.7%
2/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
6/26 • Number of events 7 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
100.0%
26/26 • Number of events 108 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
69.2%
18/26 • Number of events 44 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
abdominal bloating
|
11.5%
3/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
acid reflux
|
15.4%
4/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
vomiting
|
46.2%
12/26 • Number of events 25 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
7.7%
2/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Nervous system disorders
Headache
|
30.8%
8/26 • Number of events 11 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
7.7%
2/26 • Number of events 6 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Blood and lymphatic system disorders
anemia
|
15.4%
4/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
2/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.4%
4/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Vascular disorders
Hypertension
|
23.1%
6/26 • Number of events 13 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Injection site reaction
|
76.9%
20/26 • Number of events 53 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Psychiatric disorders
Insomnia
|
34.6%
9/26 • Number of events 11 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Investigations
Lymphopenia
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
15.4%
4/26 • Number of events 8 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Psychiatric disorders
Mood alteration-depression
|
15.4%
4/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Mouth dryness
|
7.7%
2/26 • Number of events 5 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
7.7%
2/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle pain)
|
46.2%
12/26 • Number of events 14 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Gastrointestinal disorders
Nausea
|
84.6%
22/26 • Number of events 70 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
11.5%
3/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Pain
|
38.5%
10/26 • Number of events 19 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Renal and urinary disorders
Proteinuria
|
11.5%
3/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.5%
3/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
19.2%
5/26 • Number of events 8 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Rigors, chills
|
100.0%
26/26 • Number of events 71 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Infections and infestations
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
46.2%
12/26 • Number of events 24 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
General disorders
Sweating (diaphoresis)
|
11.5%
3/26 • Number of events 6 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Nervous system disorders
Syncope (fainting)
|
7.7%
2/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Nervous system disorders
Taste disturbance (dysgeusia)
|
46.2%
12/26 • Number of events 25 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
2/26 • Number of events 2 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
7.7%
2/26 • Number of events 4 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
26.9%
7/26 • Number of events 9 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Investigations
Weight loss
|
50.0%
13/26 • Number of events 17 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
|
Infections and infestations
Wound-infectious
|
7.7%
2/26 • Number of events 3 • 18 Months
From beginning of treatment to 30 days after treatment. The maximum time was 18 months
|
Additional Information
Dr. Jorge Garcia
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-7774
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place