Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055237
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2003-02-21
Brief Title:
Bevacizumab to Treat Kaposis Sarcoma in HIV-Positive and HIV-Negative Patients
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of Intravenous Recombinant Humanized Anti-Vascular Endothelial Cell Growth Factor Antibody Bevacizumab in Classical HIV-Negative and in AIDS-Associated Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome AIDS and AIDS-associated Kaposis sarcoma KS KS tumors depend on the formation of new blood vessels for their growth Bevacizumab is an antibody to a protein called vascular endothelial growth factor VEGF that is produced by the body and is involved in blood vessel growth Bevacizumab may block the action of VEGF and thus help shrink KS lesions
Patients 18 years of age and older with Kaposis sarcoma that is restricted to the skin and is not life threatening may be eligible for this study Candidates will be screened with a medical history and physical examination blood and urine tests electrocardiogram EKG chest x-ray and if needed imaging studies to evaluate internal tumors
Participants will receive bevacizumab intravenously by vein once a week for 2 weeks and then every 3 weeks at the National Institutes of Health NIH Clinical Center The first infusion takes about 90 minutes the second takes about 60 minutes and subsequent infusions take about 30 minutes Infusions may take longer however if the drug is better tolerated at a slower infusion rate Patients will be evaluated with the following tests and procedures
Physical examination assessment of drug side effects measurement of KS lesions and photographs of lesions once a week for the first 6 weeks of therapy and then every 3 weeks
cluster of differentiation 4 CD4 cell counts and human immunodeficiency virus HIV viral load in HIV-positive patients every 12 weeks
Biopsies of lesions upon entering the study at week 12 and at the time of a response of the tumor to therapy or at the end of treatment if treatment ends at week 18 or later
Additional biopsies if requested Additional biopsies are not required
Other procedures such as computed tomography CT or magnetic resonance imaging MRI scans if medically indicated
Patients may continue bevacizumab therapy indefinitely if they are benefiting from it as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open
Patients 18 years of age and older with Kaposis sarcoma that is restricted to the skin and is not life threatening may be eligible for this study Candidates will be screened with a medical history and physical examination blood and urine tests electrocardiogram EKG chest x-ray and if needed imaging studies to evaluate internal tumors
Participants will receive bevacizumab intravenously by vein once a week for 2 weeks and then every 3 weeks at the National Institutes of Health NIH Clinical Center The first infusion takes about 90 minutes the second takes about 60 minutes and subsequent infusions take about 30 minutes Infusions may take longer however if the drug is better tolerated at a slower infusion rate Patients will be evaluated with the following tests and procedures
Physical examination assessment of drug side effects measurement of KS lesions and photographs of lesions once a week for the first 6 weeks of therapy and then every 3 weeks
cluster of differentiation 4 CD4 cell counts and human immunodeficiency virus HIV viral load in HIV-positive patients every 12 weeks
Biopsies of lesions upon entering the study at week 12 and at the time of a response of the tumor to therapy or at the end of treatment if treatment ends at week 18 or later
Additional biopsies if requested Additional biopsies are not required
Other procedures such as computed tomography CT or magnetic resonance imaging MRI scans if medically indicated
Patients may continue bevacizumab therapy indefinitely if they are benefiting from it as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open
Detailed Description:
BACKGROUND
This is a phase II study to determine the activity of bevacizumab a putative antiangiogenic agent in Kaposis sarcoma KS Bevacizumab is a humanized recombinant antibody to vascular endothelial cell growth factor VEGF an important cytokine in the pathogenesis of KS
OBJECTIVES
To assess the antitumor effect of bevacizumab 15 mgkg administered intravenously once every three weeks in patients with human immunodeficiency virus HIV-associated Kaposis sarcoma KS Other objectives include assessment of the antitumor effect of bevacizumab 15 mgkg administered intravenously once every three weeks in patients with classical KS assessment of the toxicity profile of bevacizumab in HIV-infected and HIV-negative patients with KS exploration in a preliminary fashion effect of bevacizumab on KS progression free survival and study of a number of biochemical parameters including stromal cell-derived factor-1 SDF-1 expression in KS lesions human herpes virus-8 HHV-8 viral load in peripheral blood mononuclear cells serum vascular endothelial growth factor VEGF levels over the course of treatment and changes in viral interleukin 6 IL-6 levels over the course of treatment
ELIGIBILITY
Key eligibility parameters include HIV-associated or classical Kaposis sarcoma age greater than or equal to 18 years and life expectancy greater than 6 months Patients with HIV infection must have either KS progression on a regimen of highly active antiretroviral therapy HAART for at least one month or no KS regression while on an optimized regimen of HAART for 4 months or longer
DESIGN
Patients will be sequentially enrolled administered a loading dose of 15 mgkg bevacizumab intravenously on day 1 and then administered 15 mgkg bevacizumab intravenously every 3 weeks beginning one week after the loading dose The drug will be temporarily discontinued for toxicity intercurrent major surgical procedures or other factors that would pose a safety concern Patients will undergo a biopsy of a KS lesion at entry on cycle 4 day 21 and at the time of a formal response or when the patient stops treatment Patients will undergo a number of other tests as well including blood tests and non-invasive imaging studies of KS lesions
This is a phase II study to determine the activity of bevacizumab a putative antiangiogenic agent in Kaposis sarcoma KS Bevacizumab is a humanized recombinant antibody to vascular endothelial cell growth factor VEGF an important cytokine in the pathogenesis of KS
OBJECTIVES
To assess the antitumor effect of bevacizumab 15 mgkg administered intravenously once every three weeks in patients with human immunodeficiency virus HIV-associated Kaposis sarcoma KS Other objectives include assessment of the antitumor effect of bevacizumab 15 mgkg administered intravenously once every three weeks in patients with classical KS assessment of the toxicity profile of bevacizumab in HIV-infected and HIV-negative patients with KS exploration in a preliminary fashion effect of bevacizumab on KS progression free survival and study of a number of biochemical parameters including stromal cell-derived factor-1 SDF-1 expression in KS lesions human herpes virus-8 HHV-8 viral load in peripheral blood mononuclear cells serum vascular endothelial growth factor VEGF levels over the course of treatment and changes in viral interleukin 6 IL-6 levels over the course of treatment
ELIGIBILITY
Key eligibility parameters include HIV-associated or classical Kaposis sarcoma age greater than or equal to 18 years and life expectancy greater than 6 months Patients with HIV infection must have either KS progression on a regimen of highly active antiretroviral therapy HAART for at least one month or no KS regression while on an optimized regimen of HAART for 4 months or longer
DESIGN
Patients will be sequentially enrolled administered a loading dose of 15 mgkg bevacizumab intravenously on day 1 and then administered 15 mgkg bevacizumab intravenously every 3 weeks beginning one week after the loading dose The drug will be temporarily discontinued for toxicity intercurrent major surgical procedures or other factors that would pose a safety concern Patients will undergo a biopsy of a KS lesion at entry on cycle 4 day 21 and at the time of a formal response or when the patient stops treatment Patients will undergo a number of other tests as well including blood tests and non-invasive imaging studies of KS lesions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-0110 | None | None | None |