Protocol Number: 98-C-0159

Title:

Treatment of Patients with Metastatic Renal Cell Carcinoma with Neutralizing Antibody to Vascular Endothelial Growth Factor (VEGF)

Number:

98-C-0159

Summary:

Patients with measurable metastatic renal cell cancer will be randomized to receive no immediate therapy (placebo), therapy with 3 mg/kg of rhuMAb VEGF, or therapy with 10 mg/kg of rhuMAb VEGF antibody in blinded fashion. Primary endpoints are time to disease progression and partial or complete responses. Secondary endpoints are toxicity assessment, evaluation of drug and VEGF levels and overall survival. Patients initially randomized to placebo will be offered rhuMAb VEGF at the time of disease progression if appropriate.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Angiogenesis

Vascular Permeability Factor (VPF)

Vascular Endothelium

Von Hippel-Lindau Gene

Recruitment Keywords:

None

Conditions:

Neoplasm Metastasis

Renal Cell Carcinoma

Investigational Drug(s):

rhu MAb VEGF

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

The biology of vascular endothelial growth factor

Reversion of deregulated expression of vascular endothelial growth factor in human renal carcinoma cells by von Hippel-Lindau tumor suppressor protein

Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumor growth in vivo

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004