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| ID | Type | Description | Link |
|---|---|---|---|
| CO03805 | |||
| A534260 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/MEDICINE*H | Other Identifier | UW Madison |
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slow accrual
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.
The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL2 | Drug | Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid | 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. | CT scans obtained at baseline, then every 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Liu, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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The study opened to accrual on 09/30/2003 and closed to accrual on 08/05/2008. Recruitment occured in a medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid | 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. | 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. | Posted | Number | participants | CT scans obtained at baseline, then every 2 cycles |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study coordinator | University of Wisconsin Carbone Cancer Center | (608) 263-7107 | uwcccgu@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Zoledronic acid | Drug | Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg. |
|
|
| Time frame is from study entry until time to disease progression and time to death, up to 50 months |
| Number of Participants With Toxicities | Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events. | Baseline to 30 days after last dose of study treatment |
| Number of Participants With Immunologic Responses | 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. | baseline to cycle 2 day 8 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks | 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 | 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 | Posted | Number | participants | Time frame is from study entry until time to disease progression and time to death, up to 50 months |
|
|
|
| Secondary | Number of Participants With Toxicities | Patients were observed for toxicities. The National Cancer Institute Common Terminology Criteria Version 2.0 was used to categorize and report adverse events. | 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 | Posted | Number | participants | Baseline to 30 days after last dose of study treatment |
|
|
|
| Secondary | Number of Participants With Immunologic Responses | 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. | One patient did not receive study treatment and so was not included in the analysis. | Posted | Number | participants | baseline to cycle 2 day 8 |
|
|
|
| 2 |
| 11 |
| 11 |
| 11 |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgias | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Bone pains | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hand edema | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Infection NOS | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGPT (ALT) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| SGOT (AST) | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| GGT | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Anxiety/Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Dry Eye | Eye disorders | CTCAE (2.0) | Systematic Assessment |
|
| Weight Loss | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Lipase | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
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| Non-Cardiac Chest | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Myalgias/Arthralgias | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Musculocskeletal | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| injection site reaction | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Taste changes | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| Thyroiditis | General disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |