Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003107
Status:
COMPLETED
Last Update Posted:
2014-09-10
First Post:
1999-11-01
Brief Title:
Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
A Phase I Trial of Recombinant Human Interleukin-12 After High-Dose Therapy and Autologous Hematopoietic Stem Cell Support
Status:
COMPLETED
Status Verified Date:
2014-09
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-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-12 in treating patients who have hematologic cancer or solid tumor
PURPOSE Phase I trial to study the effectiveness of interleukin-12 in treating patients who have hematologic cancer or solid tumor
Detailed Description:
OBJECTIVES I Assess the safety and maximum tolerated dose of interleukin-12 IL-12 in patients with hematologic malignancies or solid tumors who have undergone high-dose chemotherapy and autologous stem cell transplantation II Evaluate the hematologic and immunologic effects of IL-12 in these patients
OUTLINE This is a dose-escalation study Patients receive interleukin-12 IL-12 IV as a single test dose followed by 2 weeks of rest Patients then receive IL-12 IV daily for 5 days followed by 16 days of rest for up to 6 courses Cohorts of 3-5 patients receive escalating doses of IL-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive interleukin-12 IL-12 IV as a single test dose followed by 2 weeks of rest Patients then receive IL-12 IV daily for 5 days followed by 16 days of rest for up to 6 courses Cohorts of 3-5 patients receive escalating doses of IL-12 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity Patients are followed until death
PROJECTED ACCRUAL A total of 12 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-T97-0027 | None | None | None |
| IUMC-9708-05 | None | None | None |