Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00301990
Other study ID # CDR0000460074
Secondary ID UCLA-050658-01DM
Status Recruiting
Phase Phase 2
First received March 10, 2006
Last updated January 9, 2014
Start date September 2005

Study information

Verified date April 2007
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical 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. 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.


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.


Other known NCT identifiers
  • NCT00142142

Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
aldesleukin

bevacizumab


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York
United States University of Virginia Cancer Center Charlottesville Virginia
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Jonsson Comprehensive Cancer Center at UCLA Los Angeles California
United States Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States UPMC Cancer Centers Pittsburgh Pennsylvania
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response No
Primary Progression-free and overall survival No
Secondary Comparison of response and survival with historical data No
Secondary Toxicity Yes
Secondary Time to disease progression No
Secondary Pharmacokinetics and pharmacodynamics No
Secondary Correlation of serum VEGF levels, DC function, TCR zeta chain expression, and arginase or arginine levels with toxicity, response, and survival Yes
Secondary Utility of known prognostic criteria No
See also
  Status Clinical Trial Phase
Completed NCT00541008 - Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer Phase 2
Completed NCT03520231 - Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases Phase 2
Recruiting NCT04623502 - An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy N/A
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Active, not recruiting NCT01529658 - Renal Hypothermia During Partial Nephrectomy N/A
Completed NCT01048892 - Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features Phase 1
Withdrawn NCT00769990 - Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases Phase 1/Phase 2
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Terminated NCT00896467 - Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy N/A
Completed NCT00467077 - Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer Phase 2
Completed NCT00098943 - NGR-TNF in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT00089102 - Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney Cancer Phase 2
Terminated NCT00899860 - Gene Expression in Normal Tissue and Tumor Tissue From Patients Who Have Undergone Surgery For Kidney Cancer N/A
Completed NCT00021021 - RPI.4610 in Treating Patients With Metastatic Kidney Cancer Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
Completed NCT00006968 - Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer Phase 1/Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1