Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492440
Status:
TERMINATED
Last Update Posted:
2012-10-18
First Post:
2007-06-25
Brief Title:
Interleukin-7 in Treating Patients With Metastatic Melanoma or Locally Advanced or Metastatic Kidney Cancer
Sponsor:
Cytheris SA
Organization:
Cytheris SA
Study Overview
Official Title:
A Phase I Study of Subcutaneous CYT 107 Interleukin-7 in Refractory Metastatic Melanoma or Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2012-10
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:
RATIONALE Interleukin-7 may stimulate the white blood cells to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer
PURPOSE This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety of recombinant interleukin-7 IL-7 in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma
Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients
Determine the safety of higher doses of recombinant IL-7 in these patients
Determine the maximum tolerated dose of recombinant IL-7 in these patients
Determine the biologically active dose of recombinant IL-7 in these patients
Secondary
Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients
Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients
Determine the potential antitumor effect of recombinant IL-7 in these patients
Determine the dose and administration schedule of recombinant IL-7 in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to lymphocyte count normal lymphocyte count CD4 T cells 400mm3 vs lymphopenic CD4 T cells 400mm3 Patients are assigned to 1 of 2 treatment groups
Group 1 normal lymphocyte count Patients receive recombinant interleukin-7 IL-7 subcutaneously once a week to determine an active dose for up to 3 weeks in the absence of disease progression or unacceptable toxicity
Group 2 lymphopenic Patients receive recombinant IL-7 subcutaneously once a week for up to 3 weeks at one dose level below the active dose determined in group 1
Cohorts of 3-6 patients from each group receive escalating doses of recombinant IL-7 until the maximum tolerated dose MTD is determined The MTD is the defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 30 additional patients may be treated at the MTD
Patients undergo blood and bone marrow collection periodically for pharmacokinetic pharmacodynamic and immunological studies Samples are analyzed for the presence of antibodies and proteins via ELISA CD3 CD4 and CD8 T cell counts CD127 Ki-67 and Bcl-2 expression in CD4 and CD8 T cells and CD19 B cell counts via flow cytometry and clonal B cell proliferation via PCR and flow cytometry
After completion of study treatment patients are followed at 3 months
Primary
Determine the safety of recombinant interleukin-7 IL-7 in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma
Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients
Determine the safety of higher doses of recombinant IL-7 in these patients
Determine the maximum tolerated dose of recombinant IL-7 in these patients
Determine the biologically active dose of recombinant IL-7 in these patients
Secondary
Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients
Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients
Determine the potential antitumor effect of recombinant IL-7 in these patients
Determine the dose and administration schedule of recombinant IL-7 in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to lymphocyte count normal lymphocyte count CD4 T cells 400mm3 vs lymphopenic CD4 T cells 400mm3 Patients are assigned to 1 of 2 treatment groups
Group 1 normal lymphocyte count Patients receive recombinant interleukin-7 IL-7 subcutaneously once a week to determine an active dose for up to 3 weeks in the absence of disease progression or unacceptable toxicity
Group 2 lymphopenic Patients receive recombinant IL-7 subcutaneously once a week for up to 3 weeks at one dose level below the active dose determined in group 1
Cohorts of 3-6 patients from each group receive escalating doses of recombinant IL-7 until the maximum tolerated dose MTD is determined The MTD is the defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 30 additional patients may be treated at the MTD
Patients undergo blood and bone marrow collection periodically for pharmacokinetic pharmacodynamic and immunological studies Samples are analyzed for the presence of antibodies and proteins via ELISA CD3 CD4 and CD8 T cell counts CD127 Ki-67 and Bcl-2 expression in CD4 and CD8 T cells and CD19 B cell counts via flow cytometry and clonal B cell proliferation via PCR and flow cytometry
After completion of study treatment patients are followed at 3 months
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 |
|---|---|---|---|
| CLI-107-04 | OTHER | Cytheris | None |
| 07-C-0114 | OTHER | None | None |