Kidney CancerPhase 2NCT00853021
Bevacizumab and Aldesleukin in Treating Patients With Metastatic Clear Cell Carcinoma of the Kidney
A Phase 2 study testing aldesleukin and bevacizumab in people with Kidney Cancer, run by Jorge A. Garcia, MD at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- aldesleukin and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma (RCC) of clear cell histology with or without sarcomatoid features
- Metastatic disease
- No non-clear cell RCC (i.e., papillary, collecting-duct, or chromophobe)
- Good- or intermediate-risk category as defined by having ≤ 2 of the following factors:
- No prior nephrectomy
- Karnofsky performance status < 80%
- Hemoglobin < 12 g/dL
- Corrected calcium > 10.0 mg/dL
- LDH > 1.5 times upper limit of normal (ULN)
- Must have undergone a nephrectomy at least 28 days ago
- Measurable or evaluable disease by RECIST
- No significant effusions and/or ascites
- No prior or concurrent brain or CNS metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy of ≥ 3 months
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.5 g/dL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST ≤ 5.0 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN (≤ 10 times ULN with bone metastasis)
- Calcium ≤ 12 mg/dL
- Urine protein:creatinine ratio ≤ 1.0
- INR ≤ 1.5 (unless receiving warfarin therapy)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled seizure disorder
- No known HIV positivity
- No local or systemic infections requiring IV antibiotics within the past 28 days
- No significant traumatic injury in the past 28 days
- No serious non-healing wound, ulcer, or acute bone fracture
- No evidence of bleeding diathesis or coagulopathy
- No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in-situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for > 3 years
- No history of serious systemic or severe cardiovascular disease, including any of the following:
- Arterial thromboembolic event (including transient ischemic attack)
- Cerebrovascular accident
- Unstable angina
- Myocardial infarction within the past 6 months
- Uncontrolled hypertension (BP > 160/110 mm Hg on medication)
- Uncontrolled cardiac arrhythmia
- Congestive heart failure
- Angina pectoris
- NYHA class III-IV cardiovascular disease
- Peripheral vascular disease ≥ grade II
- No history of abdominal fistula and/or bowel or gastric perforation within the past 6 months
- No history of other diseases, metabolic dysfunction, or physical or laboratory examination findings giving reasonable suspicion of a disease or condition that contraindicate the use of investigational drugs, or that might affect the interpretation of study results, or that render patient at high-risk for treatment complications
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior organ allografts
- No prior systemic therapy for metastatic clear cell renal cell carcinoma
- At least 4 weeks since prior radiotherapy and recovered
- Radiotherapy for control of pain from skeletal lesions allowed within the past 28 days
- More than 12 months since prior adjuvant therapy
- More than 7 days since prior fine-needle aspirations or core biopsies
- More than 28 days since prior and no concurrent major surgery requiring general anesthesia or open biopsy
- No concurrent aspirin, corticosteroids (except at replacement doses), barbiturates, or other investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.
Secondary
- To determine the objective response rate in patients receiving this regimen.
- To determine the time to progression in patients receiving this regimen.
- To evaluate immunomodulatory effects of this regimen in patients
- To evaluate the toxicity of this regimen in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days -14, 1, 15, 29, and 42 and aldesleukin subcutaneously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving complete response after completion of study therapy may receive 1 additional course of therapy.
After completion of study therapy, patients are followed periodically.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin, bevacizumab
- Keywords
- clear cell renal cell carcinoma, recurrent renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
Also called rIL-2 (NSC3773364), Proleukin®, Chiron
SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.
bevacizumabBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and Aldesleukin | Experimental | Not described Receives: Biological: aldesleukin; Biological: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
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.
Measured: From baseline (day -14) to disease progression (reported at 2 years)
Secondary outcomes (3)
Objective Response Rate (Complete and Partial Response)
Objective 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.
Measured: 4 weeks after end of treatment
Percentage of Patients With Constitutional Adverse Events
Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of fatigue and fever/chills
Measured: From start of treatment to 30 days after treatment
Percentage of Patients With Neutropenia
Toxicity Criteria: The NCI graded common clinical toxicity scale (NCI Version 2.0) will be employed to grade observed toxicity of neutropenia
Measured: From start of treatment to 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jorge A. Garcia, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Jorge A. Garcia, MD, Case Comprehensive Cancer Center
- Investigators
- Jorge A. Garcia, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853021
- Sponsor's protocol ID
- CASE8804
- Other IDs
- P30CA043703, CASE8804, 7493
- Status last verified
- May 2019
- First submitted
- 26 Feb 2009
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
- ClinicalTrials.gov ID
- NCT00853021
- Acronym / sponsor ID
- CASE8804
- Conditions
- Kidney Cancer
- Keywords
- clear cell renal cell carcinoma, recurrent renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jorge A. Garcia, MDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Posted 24 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
Detailed description
OBJECTIVES:
Primary
- To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.
Secondary
- To determine the objective response rate in patients receiving this regimen.
- To determine the time to progression in patients receiving this regimen.
- To evaluate immunomodulatory effects of this regimen in patients
- To evaluate the toxicity of this regimen in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days -14, 1, 15, 29, and 42 and aldesleukin subcutaneously on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving complete response after completion of study therapy may receive 1 additional course of therapy.
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and Aldesleukin | Experimental | Biological: aldesleukin, Biological: bevacizumab |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukinAlso: rIL-2 (NSC3773364), Proleukin®, ChironSQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break. | Biological | Bevacizumab and Aldesleukin |
| bevacizumabBevacizumab 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. | Biological | Bevacizumab and Aldesleukin |
Primary outcome
Progression Free Survival
Time frame: 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.
3 secondary outcomes
Objective Response Rate (Complete and Partial Response)
Time frame: 4 weeks after end of treatment
Percentage of Patients With Constitutional Adverse Events
Time frame: From start of treatment to 30 days after treatment
Percentage of Patients With Neutropenia
Time frame: From start of treatment to 30 days after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge A. Garcia, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin and bevacizumab in people with Kidney Cancer, run by Jorge A. Garcia, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From baseline (day -14) to disease progression (reported at 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.