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Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126490
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: aldesleukin
Drug: bevacizumab
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Aldesleukin Bevacizumab Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Major response frequency (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: September 2005
Estimated Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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:

    • 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • More than 4 months

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • No history of bleeding diathesis

Hepatic

  • See Disease Characteristics
  • 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

Renal

  • Creatinine ≤ 2.0 mg/dL
  • No proteinuria* by dipstick urinalysis OR
  • Urine protein ≤ 1,000 mg by 24-hour urine collection NOTE: *Trace proteinuria allowed

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior bevacizumab
  • At least 6 months since prior immunotherapy containing IL-2
  • At least 2 months since prior investigational antibodies

Chemotherapy

  • More than 4 weeks since prior conventional cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • No concurrent corticosteroids except replacement corticosteroids for adrenal insufficiency OR inhaled steroids for chronic obstructive pulmonary disease, asthma, or allergic rhinitis

Radiotherapy

  • 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

Surgery

  • See Disease Characteristics
  • 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

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126490

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Mayer Fishman, MD, PhD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000434852, MCC-13921, MCC-IRB-102782, NCI-6438
Study First Received: August 2, 2005
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00126490  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Urogenital Neoplasms
Bevacizumab
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Aldesleukin
Urologic Diseases
Interleukin-2
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009