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Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

Primary Purpose

Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
thalidomide
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Renal Cell Cancer focused on measuring adult solid tumor, body system/site cancer, cancer, kidney tumor, kidney/urinary cancer, recurrent renal cell cancer, renal cell cancer, solid tumor, stage IV renal cell cancer, stage, renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven unresectable advanced renal cell cancer Measurable disease Must have received or not be a suitable candidate for interleukin-2 therapy No papillary or collecting duct renal cell cancer No CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics No prior thalidomide At least 4 weeks since other prior biologic therapy No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 1,000/mm3 Platelet count at least 75,000/mm3 No coagulation disorder, active bleeding, or wound healing problem Hepatic: Total bilirubin no greater than 2.0 mg/dL (for patients with Gilbert's disease, direct bilirubin less than 0.5 mg/dL) SGOT or SGPT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No coronary artery disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically evident preexisting peripheral neuropathy

Sites / Locations

  • Surgery Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2009
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019539
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
Official Title
Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them. PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed.
Detailed Description
OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer. II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen. III. Evaluate the toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior interleukin-2 therapy (yes vs no). Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF. Following an initial loading dose, patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study over 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer
Keywords
adult solid tumor, body system/site cancer, cancer, kidney tumor, kidney/urinary cancer, recurrent renal cell cancer, renal cell cancer, solid tumor, stage IV renal cell cancer, stage, renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Minimum Age & Unit of Time
18 Years
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven unresectable advanced renal cell cancer Measurable disease Must have received or not be a suitable candidate for interleukin-2 therapy No papillary or collecting duct renal cell cancer No CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics No prior thalidomide At least 4 weeks since other prior biologic therapy No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 1,000/mm3 Platelet count at least 75,000/mm3 No coagulation disorder, active bleeding, or wound healing problem Hepatic: Total bilirubin no greater than 2.0 mg/dL (for patients with Gilbert's disease, direct bilirubin less than 0.5 mg/dL) SGOT or SGPT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No coronary artery disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically evident preexisting peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Chung-Yin Yang
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

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