Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004890
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2000-03-07
Brief Title:
Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer
Sponsor:
BioMedicines
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy
Status:
COMPLETED
Status Verified Date:
2008-01
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-2 may stimulate a persons white blood cells to kill kidney cancer cells Biomed 101 may protect normal cells from the side effects of interleukin-2
PURPOSE Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer
PURPOSE Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with renal cell cancer currently treated with interleukin-2 IL-2 II Evaluate the effect of different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity
OUTLINE This is a dose escalation study of Biomed 101 Patients receive oral Biomed 101 three times daily followed by interleukin-2 IV on days 1-5 and 16-20 Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities Patients are followed for 1 month
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
OUTLINE This is a dose escalation study of Biomed 101 Patients receive oral Biomed 101 three times daily followed by interleukin-2 IV on days 1-5 and 16-20 Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities Patients are followed for 1 month
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1708 | None | None | None |
| UCLA-9908051 | None | None | None |
| BIOMED-101-CLP-01 | None | None | None |