Completed

Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)

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What is being tested

bevacizumab

+ recombinant interferon alfa
Biological
Who is being recruted

Kidney Cancer

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2003

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer). PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma. OBJECTIVES: Primary * Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab. Secondary * Compare the time to disease progression and objective response rates in patients treated with these regimens. * Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week. * Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then annually for up to 10 years after study entry. PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Official TitleA Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: July 6, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
732 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Kidney Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma (RCC) * Conventional clear cell carcinoma * Metastatic or unresectable disease * The following characteristics and cellular types are excluded: * True papillary * Sarcomatoid features without a clear cell component * Chromophobe * Oncocytoma * Collecting duct tumor * Transitional cell carcinoma * Measurable or nonmeasurable disease, including any of the following: * Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI * The following are considered nonmeasurable disease: * Small lesions * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Irradiated lesions, unless progression is documented after radiotherapy * RCC paraffin tissue blocks or unstained slides must be available * No evidence of prior or concurrent CNS metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No history of clinically significant bleeding Hepatic * AST/ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN * No proteinuria \> 1+ * Proteinuria ≥ 2+ allowed provided protein is \< 2 g/24-hour urine collection Cardiovascular * No deep venous thrombosis within the past year * No cerebrovascular accident within the past year * No peripheral vascular disease with claudication on \< 1 block * No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication * No New York Heart Association class II-IV congestive heart failure * No angina pectoris requiring nitrate therapy * No myocardial infarction within the past 6 months * No other significant cardiovascular disease Pulmonary * No pulmonary embolus within the past year * No ongoing hemoptysis Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication * No delayed wound healing, ulcers, or bone fractures * No uncontrolled psychiatric disorder * No other currently active\* malignancy except nonmelanoma skin cancer NOTE: \*Disease is not considered currently active if patient completed anticancer therapy and is considered to have \< 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic immunotherapy for RCC * No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No prior systemic chemotherapy for RCC * No concurrent chemotherapy Endocrine therapy * No concurrent systemic corticosteroid therapy except the following: * Topical and inhaled steroids * Replacement therapy for adrenal insufficiency * No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated * No concurrent palliative radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered Other * No other prior systemic investigational therapy for RCC * No other prior adjuvant or neoadjuvant systemic therapy for RCC * No concurrent full-dose oral or parenteral anticoagulation\* NOTE: \*Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowed


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Treatment with interferon alfa 2b
Group II
Experimental
Addition of bevacizumab to interferon alfa 2b treatment
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 493 locations
Suspended
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, United StatesSee the location
Suspended
Huntsville HospitalHuntsville, United States
Suspended
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, United States
Suspended
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFt. Smith, United States

Completed493 Study Centers