Kidney CancerPhase 2NCT00301990
Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing aldesleukin and bevacizumab in people with Kidney Cancer, run by Jonsson Comprehensive Cancer Center at 11 sites 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 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- aldesleukin and bevacizumab
- How many people
- 65 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma (RCC) with predominantly clear cell histology
- Measurable disease
- No history of tumor-related hemorrhage
- No history of CNS or brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status ≥ 80%
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL (transfusion or recombinant erythropoietin growth factors allowed)
- AST ≤ 2 times upper limit of normal (ULN) (5 times ULN if due to liver metastases)
- Serum total bilirubin ≤ 2 times ULN (except for patients with Gilbert's disease)
- Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- FEV_1 ≥ 2.0 L or ≥ 75% of predicted
- Pulmonary function testing required for patients over age 50 or with significant pulmonary or smoking history
- No history of cerebrovascular accident or transient ischemic attacks
- No evidence of any of the following cardiac conditions*:
- Congestive heart failure
- Symptoms of coronary artery disease
- Myocardial infarction < 6 months prior to study entry
- Serious cardiac arrhythmias
- Unstable angina NOTE: *Patients > 40 years old or who have had a previous myocardial infarction > 6 months prior to study entry are required to have a negative or low probability cardiac stress test for cardiac ischemia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cancer, such as cervical carcinoma in situ, superficial bladder cancer without local recurrence, or breast cancer in situ
- Patients with a history of another invasive malignancy must be in complete remission for ≥ 5 years
- No positive serology for HIV, hepatitis B, or hepatitis C
- No significant co-morbid illness, such as uncontrolled diabetes or active infection, that would preclude study treatment
- No history of inflammatory bowel disease or other serious autoimmune disease
- Thyroiditis or rheumatoid arthritis allowed
- No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
- Proteinuria ≤ 3+ by dipstick OR proteinuria < 2 gm by 24-hour urine collection
- Urine protein:creatinine ration < 1.0
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study entry
- No significant traumatic injury within the past 28 days
- No serious, nonhealing wound, ulcer, or bone fracture
- No active bleeding
- No history of other serious hemorrhage, bleeding diathesis, or underlying coagulopathy
- No history of deep venous thrombosis, clinically significant peripheral vascular disease, or other thrombotic event
PRIOR CONCURRENT THERAPY:
- No organ allografts
- At least 4 weeks since prior radiotherapy or surgery and recovered
- No prior systemic therapy for metastatic RCC
- No prior bevacizumab or interleukin-2
- At least 2 weeks since prior steroids
- No major surgery or open biopsy within the past 28 days
- No minor surgical procedures, fine needle aspirations, or core biopsies within the past 7 days, except central venous catheter placement
- No concurrent major surgery
- No concurrent corticosteroids or other immunosuppressants
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Clinical Trials Office - Beth Israel Deaconess Medical Center, 617-667-9925
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Geoffrey R. Weiss, MD, 434-243-0066, grw3k@virginia.edu
- Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Clinical Trials Office - Barbara Ann Karmanos Cancer Institute, 313-576-9363
- Recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202-5289
Clinical Trials Office - Indiana University Cancer Center, 317-274-2552
- Recruiting
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Clinical Trials Office - Norris Cotton Cancer Center, 603-650-7609, cancerhelp@dartmouth.edu
- Recruiting
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Clinical Trials Office - Jonsson Comprehensive Cancer Center a, 888-798-0719
- Recruiting
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Clinical Trials Office - Cardinal Bernardin Cancer Center, 708-226-4357
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Clinical Trials Office - Vanderbilt-Ingram Cancer Center, 800-811-8480
- Recruiting
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Clinical Trials Office - UPMC Cancer Centers, 412-647-8073
- Recruiting
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967
Clinical Trials Office - Providence Cancer Center at Providenc, 503-215-6412
- Recruiting
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
Janice P. Dutcher, MD, 718-304-7200
About this study
Official title: A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study
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. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Estimate the response, progression-free survival, and overall survival of patients with metastatic renal cell carcinoma (RCC) treated with bevacizumab and high-dose interleukin-2 (IL-2).
Secondary
- Compare the response and survival of patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone.
- Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC with the historical data of patients treated with high-dose IL-2 alone, in terms of number of doses of IL-2 administered during the first course of therapy, toxicity after the scheduled ninth dose of IL-2, and frequency of grade III and IV or unexpected or rare toxicities.
- Compare the time to disease progression in patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone.
- Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2 during course 1.
- Correlate serum vascular endothelial growth factor (VEGF) levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival of patients treated with this regimen.
- Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good vs intermediate vs poor).
Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71 during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- aldesleukin, bevacizumab
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- 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
bevacizumabBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Progression-free and overall survival
Secondary outcomes (6)
Comparison of response and survival with historical data
Toxicity
Time to disease progression
Pharmacokinetics and pharmacodynamics
Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival
Utility of known prognostic criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Fairooz F. Kabbinavar, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301990
- Sponsor's protocol ID
- CDR0000460074
- Other IDs
- UCLA-050658-01, DMS-W0454
- Status last verified
- Apr 2007
- First submitted
- 10 Mar 2006
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab and Aldesleukin in Patients With Metastatic Renal Cell Carcinoma (RCC): A Cytokine Working Group (CWG) Study
- ClinicalTrials.gov ID
- NCT00301990
- Acronym / sponsor ID
- CDR0000460074
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer, clear cell renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- First posted
- 13 Mar 2006 (estimated)
- Results
- Not posted in the source record
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. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Estimate the response, progression-free survival, and overall survival of patients with metastatic renal cell carcinoma (RCC) treated with bevacizumab and high-dose interleukin-2 (IL-2).
Secondary
- Compare the response and survival of patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone.
- Compare the toxicity of bevacizumab and high-dose IL-2 in patients with metastatic RCC with the historical data of patients treated with high-dose IL-2 alone, in terms of number of doses of IL-2 administered during the first course of therapy, toxicity after the scheduled ninth dose of IL-2, and frequency of grade III and IV or unexpected or rare toxicities.
- Compare the time to disease progression in patients with metastatic RCC treated with bevacizumab and high-dose IL-2 with the historical data of patients treated with high-dose IL-2 alone.
- Evaluate the pharmacokinetics and pharmacodynamics of bevacizumab and high-dose IL-2 during course 1.
- Correlate serum vascular endothelial growth factor (VEGF) levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival of patients treated with this regimen.
- Evaluate the utility of known prognostic criteria for RCC patients on clinical outcome.
OUTLINE: This is a multicenter study. Patients are stratified according to prognosis (good vs intermediate vs poor).
Patients receive bevacizumab IV over 30-90 minutes on days -13, 1, 15, 29, 43, 57, and 71 during course 1 and on days 1, 15, 29, 43, 57, and 71 during courses 2 and 3. Patients also receive high-dose interleukin-2 every 8 hours on days 1-5 and 15-19. Treatment repeats every 84 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| aldesleukin | Biological | – |
| bevacizumab | Biological | – |
Primary outcome
Response
Progression-free and overall survival
6 secondary outcomes
Comparison of response and survival with historical data
Toxicity
Time to disease progression
Pharmacokinetics and pharmacodynamics
Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival
Utility of known prognostic criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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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.
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, United States
Fairooz F. Kabbinavar, MD study chair
Jonsson Comprehensive Cancer Center
11 sites 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 Jonsson Comprehensive Cancer Center at 11 sites 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response. The study lists 2 primary outcomes in all. 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 10 Jan 2014.