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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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
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 groups in NCT00853021
Study groupRoleWhat they receive
Bevacizumab and AldesleukinExperimentalNot described
Receives: Biological: aldesleukin; Biological: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted27 Feb 2009 (estimated)
  2. Study startDec 2005
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

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)
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
Data monitoring committee
Yes

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.

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