Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01160445
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2010-07-09
Brief Title:
Phase II Study of Aldesleukin IL-2 Following the Administration of Zanolimumab Anti-CD4mAb in Metastatic Melanoma and Metastatic Renal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Study of Aldesleukin IL-2 Following the Administration of Zanolimumab Anti-CD4mAb in Metastatic Melanoma and Metastatic Renal Cancer
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because we were not able to obtain the study drug
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Aldesleukin IL-2 is a drug that can help to shrink tumors in some patients with metastatic renal cancer and metastatic melanoma It is possible that removing certain white blood cells known as CD4 cells before IL-2 treatment may improve the treatment effects
Zanolimumab is an antibody that works by destroying CD4 cells in the blood Researchers are interested in determining whether zanolimumab can improve the results of IL-2 treatment if it is given before during and after IL-2 treatment In addition further research with zanolimumab may provide more information on how IL-2 treatment causes tumors to stop growing or shrink
Objectives
- To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in individuals with metastatic cancer
Eligibility
- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or metastatic kidney cancer
Design
Eligible participants will be screened with a full physical examination and medical history imaging studies and blood samples including leukapheresis to remove a sample of white blood cells for testing purposes Participants may also have a colonoscopy and biopsies if they have received previous treatments that have been known to cause colon damage
Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks
Zanolimumab will be given on an outpatient basis during weeks 1 through 4 6 8 and 9 In weeks 5 and 7 participants will receive zanolimumab as an inpatient in addition to IL-2 therapy
Inpatient IL-2 treatment will be given during weeks 5 and 7 Up to 15 doses of IL-2 treatment will be given over a maximum of 5 days followed by inpatient recovery time
During week 5 participants will have tumor imaging studies prior to receiving zanolimumab and IL-2 treatment
About 2 weeks after the treatment period participants will return to the clinical center for a 2-day evaluation with a physical examination imaging studies and blood samples
Participants whose tumors have responded to treatment will be offered up to two additional courses of treatment starting 6 to 8 weeks after the last IL-2 dose Subsequent courses will be given exactly as described above in the initial course of treatment Participants whose tumors do not respond to treatment will have follow-up evaluations as required by the study researchers
Aldesleukin IL-2 is a drug that can help to shrink tumors in some patients with metastatic renal cancer and metastatic melanoma It is possible that removing certain white blood cells known as CD4 cells before IL-2 treatment may improve the treatment effects
Zanolimumab is an antibody that works by destroying CD4 cells in the blood Researchers are interested in determining whether zanolimumab can improve the results of IL-2 treatment if it is given before during and after IL-2 treatment In addition further research with zanolimumab may provide more information on how IL-2 treatment causes tumors to stop growing or shrink
Objectives
- To evaluate the effectiveness of IL-2 treatment in conjunction with zanolimumab in individuals with metastatic cancer
Eligibility
- Individuals at least 18 years of age who have been diagnosed with metastatic melanoma or metastatic kidney cancer
Design
Eligible participants will be screened with a full physical examination and medical history imaging studies and blood samples including leukapheresis to remove a sample of white blood cells for testing purposes Participants may also have a colonoscopy and biopsies if they have received previous treatments that have been known to cause colon damage
Participants will be treated with zanolimumab and IL-2 treatment for 9 weeks
Zanolimumab will be given on an outpatient basis during weeks 1 through 4 6 8 and 9 In weeks 5 and 7 participants will receive zanolimumab as an inpatient in addition to IL-2 therapy
Inpatient IL-2 treatment will be given during weeks 5 and 7 Up to 15 doses of IL-2 treatment will be given over a maximum of 5 days followed by inpatient recovery time
During week 5 participants will have tumor imaging studies prior to receiving zanolimumab and IL-2 treatment
About 2 weeks after the treatment period participants will return to the clinical center for a 2-day evaluation with a physical examination imaging studies and blood samples
Participants whose tumors have responded to treatment will be offered up to two additional courses of treatment starting 6 to 8 weeks after the last IL-2 dose Subsequent courses will be given exactly as described above in the initial course of treatment Participants whose tumors do not respond to treatment will have follow-up evaluations as required by the study researchers
Detailed Description:
Background
Zanolimumab is a human monoclonal antibody mAb that specifically recognizes CD4 protein expressed on a subset of T lymphocytes and on monocytes from humans and non-human primates
Ongoing clinical studies have identified a 14 mgkg dose of zanolimumab weekly as a safe and efficacious dose Toxicities of zanolimumab included headache influenza-like illness injectioninfusion site reaction nasopharyngitis pyrexia diarrhea fatigue and cytokine release syndrome at the time of infusion
The current protocol is based on the hypothesis that transient elimination of CD4 T-regulatory cells with zanolimumab will enhance the clinical effectiveness of aldesleukin IL-2 administration by decreasing T-regulatory cell generation
Objectives
Primary objective
Determine the ability of a combination of aldesleukin and zanolimumab anti-CD4 mAb administration to mediate tumor regression in patients with metastatic melanoma and metastatic kidney cancer
Secondary objectives
Determine the rate of depletion and repopulation of CD4 cells
Determine the toxicity of this treatment
Determine the potential for pharmacokinetic interaction between zanolimumab and aldesleukin
Eligibility
Patients who are 18 years of age or older must have
measurable metastatic melanoma or metastatic kidney cancer
clinical performance status of Eastern Cooperative Oncology Group ECOG 0 or 1
Patients may not have
previously received high dose aldesleukin
Design
Patients will receive zanolimumab at a dose of 14 mgkg as an intravenous iv infusion weekly for 9 weeks After the fifth and seventh dose of zanolimumab aldesleukin will administered as an iv bolus at a dose of 720000 IUkg every 8 hours for a maximum of 15 doses
Patients will undergo complete evaluation of tumor with physical examination computed tomography CT and clinical laboratory evaluation 2 weeks after zanolimumab administration If the patient has stable disease SD or tumor shrinkage repeat complete evaluations will be performed every 1-3 months After the first year patients continuing to respond will be followed with this evaluation every 3-4 months until off study criteria are met
If patients have stable disease or a partial response to treatment after the initial evaluation or if a patient recurs or progresses after a clinical response they may be eligible for re-treatment
Patients will be entered into one of two strata metastatic melanoma or metastatic renal cancer Each of the strata will be conducted using an optimal two-stage phase II design to rule out an unacceptably low 15 clinical response rate in favor of a modestly high response rate of 35 p1035
Zanolimumab is a human monoclonal antibody mAb that specifically recognizes CD4 protein expressed on a subset of T lymphocytes and on monocytes from humans and non-human primates
Ongoing clinical studies have identified a 14 mgkg dose of zanolimumab weekly as a safe and efficacious dose Toxicities of zanolimumab included headache influenza-like illness injectioninfusion site reaction nasopharyngitis pyrexia diarrhea fatigue and cytokine release syndrome at the time of infusion
The current protocol is based on the hypothesis that transient elimination of CD4 T-regulatory cells with zanolimumab will enhance the clinical effectiveness of aldesleukin IL-2 administration by decreasing T-regulatory cell generation
Objectives
Primary objective
Determine the ability of a combination of aldesleukin and zanolimumab anti-CD4 mAb administration to mediate tumor regression in patients with metastatic melanoma and metastatic kidney cancer
Secondary objectives
Determine the rate of depletion and repopulation of CD4 cells
Determine the toxicity of this treatment
Determine the potential for pharmacokinetic interaction between zanolimumab and aldesleukin
Eligibility
Patients who are 18 years of age or older must have
measurable metastatic melanoma or metastatic kidney cancer
clinical performance status of Eastern Cooperative Oncology Group ECOG 0 or 1
Patients may not have
previously received high dose aldesleukin
Design
Patients will receive zanolimumab at a dose of 14 mgkg as an intravenous iv infusion weekly for 9 weeks After the fifth and seventh dose of zanolimumab aldesleukin will administered as an iv bolus at a dose of 720000 IUkg every 8 hours for a maximum of 15 doses
Patients will undergo complete evaluation of tumor with physical examination computed tomography CT and clinical laboratory evaluation 2 weeks after zanolimumab administration If the patient has stable disease SD or tumor shrinkage repeat complete evaluations will be performed every 1-3 months After the first year patients continuing to respond will be followed with this evaluation every 3-4 months until off study criteria are met
If patients have stable disease or a partial response to treatment after the initial evaluation or if a patient recurs or progresses after a clinical response they may be eligible for re-treatment
Patients will be entered into one of two strata metastatic melanoma or metastatic renal cancer Each of the strata will be conducted using an optimal two-stage phase II design to rule out an unacceptably low 15 clinical response rate in favor of a modestly high response rate of 35 p1035
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 10-C-0145 | None | None | None |