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Recurrent Renal Cell CarcinomaPhase 2NCT00126490

Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

A Phase 2 study testing Aldesleukin, Bevacizumab and Laboratory Biomarker Analysis in people with Recurrent Renal Cell Carcinoma and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) 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

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aldesleukin, Bevacizumab and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Mar 2005to Aug 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed renal cell cancer
  • Metastatic disease
  • More than 75% clear cell histology
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No prior refractory disease, defined as clinical or radiologic progression, during or within 3 months after completion of prior interleukin-2 (IL-2)
  • Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria:
Show all 62Show fewer
  • Hemoglobin > 10 g/dL (except for patients with hereditary hemoglobinopathy)
  • ECOG performance status 0-1 (required)
  • Calcium normal (corrected)
  • Patients with hypercalcemia due to malignancy allowed provided it has been controlled for > 1 month
  • Primary tumor treated or resected by complete nephrectomy, partial nephrectomy, radiofrequency ablation, or other local ablation
  • Lactic dehydrogenase < 1.5 times upper limit of normal (ULN)
  • No history of or current brain or CNS metastasis by CT scan or MRI within the past 30 days
  • Performance status - ECOG 0-1
  • More than 4 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • No history of bleeding diathesis
  • PTT < 1.5 times ULN
  • INR < 1.5
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • No chronic hepatitis B or C
  • Creatinine ≤ 2.0 mg/dL
  • No proteinuria* by dipstick urinalysis
  • Urine protein ≤ 1,000 mg by 24-hour urine collection
  • No symptomatic congestive heart failure
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 160 mm Hg and diastolic BP > 90 mm Hg
  • No cardiac arrhythmia
  • No peripheral vascular disease ≥ grade 2
  • No clinically significant peripheral artery disease
  • None of the following arterial thromboembolic events within the past 6 months:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina pectoris
  • Myocardial infarction
  • Not pregnant
  • No nursing during and for 3 months after completion of study treatment
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and for 3 months after completion of study treatment
  • No active infection requiring parenteral antibiotics
  • No known HIV positivity
  • No history of allergic reaction to antibody drugs or IL-2
  • No psychiatric illness or social situation that would preclude study compliance
  • No non-healing wound or fracture
  • No insulin-dependent diabetes
  • No other uncontrolled illness
  • No other malignancy requiring active treatment within the past 2 years except nonmelanoma skin cancer
  • No prior bevacizumab
  • At least 6 months since prior immunotherapy containing IL-2
  • At least 2 months since prior investigational antibodies
  • More than 4 weeks since prior conventional cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent corticosteroids except replacement corticosteroids for adrenal insufficiency OR inhaled steroids for chronic obstructive pulmonary disease, asthma, or allergic rhinitis
  • More than 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to the only site of measurable disease unless there has been subsequent disease progression
  • More than 4 weeks since prior major surgery
  • At least 24 hours since prior minor surgical procedure, placement of vascular access device, or fine needle aspiration
  • At least 30 days since prior and no other concurrent investigational agents
  • More than 10 days since prior anticoagulants
  • Low-dose anticoagulants for maintenance of vascular access device patency allowed
  • No concurrent therapeutic warfarin, including warfarin for treatment of deep vein thrombosis or pulmonary embolism
  • No other concurrent anticancer therapy

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the frequency of major response in patients with metastatic renal cell cancer treated with bevacizumab and interleukin-2.

SECONDARY OBJECTIVES I. Compare the median progression-free survival and median overall survival of patients treated with this regimen with risk-stratified historical controls from published risk models.

OUTLINE:

Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 3 months for at least 2 years.

PROJECTED ACCRUAL: Approximately 10-38 patients will be accrued for this study within 21 months.

Being tested
Aldesleukin, Bevacizumab, Laboratory Biomarker Analysis
Medical subject headings
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 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2

    Given subcutaneously

  • BevacizumabBiological

    Also called Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT00126490
Study groupRoleWhat they receive
Treatment (bevacizumab, aldesleukin)ExperimentalPatients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Aldesleukin; Biological: Bevacizumab; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year

    Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: 1 year

Secondary outcomes (4)

  1. Number of Evaluable Participants With Overall Survival (OS) at 2 Years

    Overall Survival tabulation at 2 years from start of treatment.

    Measured: 2 years from start of treatment

  2. Number of Evaluable Participants With Progression Free Survival (PFS)

    Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: Up to 2 years

  3. Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function

    Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.

    Measured: At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment

  4. Number of Participants With Possibly Related Serious Adverse Events (SAEs)

    Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Measured: Up to 30 days after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionJun 2012
  4. Study completionAug 2013

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00126490
Sponsor's protocol ID
NCI-2012-02663
Other IDs
NCI-2012-02663, CDR0000434852, NCI-6438, MCC-IRB-102782, MCC 13921, 6438, P30CA076292
Status last verified
Dec 2013
First submitted
2 Aug 2005
Last updated
30 Jun 2015

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aldesleukin, Bevacizumab and Laboratory Biomarker Analysis in people with Recurrent Renal Cell Carcinoma and Stage IV Renal Cell Cancer, run by National Cancer Institute (NCI) 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?

The sponsor lists 62 inclusion and 0 exclusion criteria. 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 30 Jun 2015. 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 30 Jul 2013). 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?

Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00126490.

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 30 Jun 2015.

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