Trial Outcomes & Findings for Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer (NCT NCT00582790)

Last Updated: 2019-11-25

Results Overview

Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

CT scans obtained at baseline, then every 2 cycles

Results posted on

2019-11-25

Participant Flow

The study opened to accrual on 09/30/2003 and closed to accrual on 08/05/2008. Recruitment occured in a medical clinic.

Participant milestones

Participant milestones
Measure	Zoledronic Acid and Interleukin-2 Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Zoledronic Acid and Interleukin-2 Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Overall Study Rapid progression of disease	1

Baseline Characteristics

Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zoledronic Acid and Interleukin-2 n=12 Participants Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Age, Continuous	56.2 Years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: CT scans obtained at baseline, then every 2 cycles

Population: Anti tumor response was measured in those patients who completed at least 1 cycle of study treatment 4 subjects did not complete 1 cycle of treatment.

Outcome measures

Outcome measures
Measure	IL2 and Zoledronic Acid n=8 Participants Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid	5 participants

SECONDARY outcome

Timeframe: Time frame is from study entry until time to disease progression and time to death, up to 50 months

Population: 8 of the 12 participants who received more than 1 cycle of therapy and were considered evaluable for time to progression. All 12 were evaluated for survival

All 12 patients were followed for survival until death. 8 participants who received more than one cycle of treatment and who were considered evaluable for response were followed until time to progression. Disease progression was determined by CT scans of the chest/abdomen/pelvis obtained every 2 cycles and based on RECIST version 1.0. Progression is defined using RECIST (V1.0) at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Outcome measures

Outcome measures
Measure	IL2 and Zoledronic Acid n=12 Participants Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks	5 participants Interval 4.0 to 33.0

SECONDARY outcome

Timeframe: Baseline to 30 days after last dose of study treatment

Population: Patients who received at least one dose of study medication. One of the 12 patients never received study medication so only 11 were evaluable for toxicity

Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events.

Outcome measures

Outcome measures
Measure	IL2 and Zoledronic Acid n=11 Participants Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Number of Participants With Toxicities	11 participants

SECONDARY outcome

Timeframe: baseline to cycle 2 day 8

Population: One patient did not receive study treatment and so was not included in the analysis.

Blood was collected to analyze T-cell populations from all patients prior to treatment on day 1 of cycles 1 and 2, and days 4 and 8 of cycles 1 and 2. Changes in gamma delta T-cell population and CD3 T-cell populations were reported.

Outcome measures

Outcome measures
Measure	IL2 and Zoledronic Acid n=11 Participants Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Number of Participants With Immunologic Responses	0 participants

Adverse Events

Zoledronic Acid and Interleukin-2

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zoledronic Acid and Interleukin-2 n=11 participants at risk Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Cardiac disorders Myocardial Infarction	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Renal and urinary disorders Creatinine	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Gastritis	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.

Other adverse events

Other adverse events
Measure	Zoledronic Acid and Interleukin-2 n=11 participants at risk Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle. patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa.
Cardiac disorders Hypotension	36.4% 4/11 • Number of events 5 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Renal and urinary disorders Creatinine	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Renal and urinary disorders Urinary Frequency	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Nausea	81.8% 9/11 • Number of events 9 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Vomitting	72.7% 8/11 • Number of events 8 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Diarrhea	63.6% 7/11 • Number of events 7 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Gastrointestinal disorders Gastritis	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Musculoskeletal and connective tissue disorders Myalgias	45.5% 5/11 • Number of events 5 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Musculoskeletal and connective tissue disorders Arthralgias	36.4% 4/11 • Number of events 5 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Musculoskeletal and connective tissue disorders Bone pains	45.5% 5/11 • Number of events 5 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Musculoskeletal and connective tissue disorders Hand edema	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Infections and infestations Urinary Tract Infection	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Infections and infestations Infection NOS	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Hepatobiliary disorders SGPT (ALT)	36.4% 4/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Hepatobiliary disorders SGOT (AST)	36.4% 4/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Hepatobiliary disorders GGT	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 3 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Nervous system disorders Headache	36.4% 4/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Psychiatric disorders Anxiety/Depression	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Respiratory, thoracic and mediastinal disorders Cough	36.4% 4/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Respiratory, thoracic and mediastinal disorders Congestion	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Eye disorders Dry Eye	9.1% 1/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Weight Loss	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Anorexia	45.5% 5/11 • Number of events 5 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Fatigue	54.5% 6/11 • Number of events 9 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Chills	81.8% 9/11 • Number of events 9 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Fever	63.6% 7/11 • Number of events 7 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Hyperglycemia	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Hypocalcemia	18.2% 2/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
Metabolism and nutrition disorders Lipase	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Non-Cardiac Chest	9.1% 1/11 • Number of events 4 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Myalgias/Arthralgias	45.5% 5/11 • Number of events 8 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Musculocskeletal	63.6% 7/11 • Number of events 7 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders injection site reaction	63.6% 7/11 • Number of events 7 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Taste changes	18.2% 2/11 • Number of events 2 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.
General disorders Thyroiditis	9.1% 1/11 • Number of events 1 • Study period: 2003 to 2006. Adverse events were collected from time of study treatment to 30 days post treatment. Adverse events listed are those with at least possibly related. All SAE's are reported regardless of whether or not they were felt related to study procedures.

Additional Information

Study coordinator

University of Wisconsin Carbone Cancer Center

Phone: (608) 263-7107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place