Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005993
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
2000-07-05
Brief Title:
Biological Therapies Following Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma Hodgkins Disease or Advanced Breast Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Immunotherapy With Subcutaneous Il-2 and Stem Cell Factor SCF for Patients With Lymphoma or Breast Cancer After Autologous Transplantation
Status:
TERMINATED
Status Verified Date:
2017-11
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 cancer cells Filgrastim and stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of cancer therapy Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by therapy used to kill cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-2 and stem cell factor following peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma Hodgkins disease or advanced breast cancer
PURPOSE Phase I trial to study the effectiveness of interleukin-2 and stem cell factor following peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma Hodgkins disease or advanced breast cancer
Detailed Description:
OBJECTIVES I Determine the safety and maximum tolerated dose of interleukin-2 IL-2 and stem cell factor SCF following autologous peripheral blood stem cell transplantation in patients with non-Hodgkins lymphoma or advanced breast cancer II Determine the effectiveness of filgrastim G-CSF and SCF as mobilizing agents in these patients
OUTLINE This is a dose escalation study of stem cell factor SCF Patients receive filgrastim G-CSF subcutaneously SC followed by SCF SC daily for 7-10 days Beginning on the fifth day of G-CSF and SCF injections peripheral blood stem cells PBSC are collected over several days PBSC are later reinfused and patients receive G-CSF SC daily until hematopoietic recovery At least 30 days but no later than 110 days following transplant patients who did not experience adverse reactions to SCF during mobilization begin posttransplant immunotherapy Patients receive interleukin-2 SC daily and SCF SC 3 times weekly for 6 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of SCF during posttransplant immunotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed at 1 week every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 27 patients will be accrued for this study within 1-15 years
OUTLINE This is a dose escalation study of stem cell factor SCF Patients receive filgrastim G-CSF subcutaneously SC followed by SCF SC daily for 7-10 days Beginning on the fifth day of G-CSF and SCF injections peripheral blood stem cells PBSC are collected over several days PBSC are later reinfused and patients receive G-CSF SC daily until hematopoietic recovery At least 30 days but no later than 110 days following transplant patients who did not experience adverse reactions to SCF during mobilization begin posttransplant immunotherapy Patients receive interleukin-2 SC daily and SCF SC 3 times weekly for 6 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of SCF during posttransplant immunotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Patients are followed at 1 week every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A maximum of 27 patients will be accrued for this study within 1-15 years
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-G00-1803 | Other Identifier | Blood and Marrow Transplantation Program | None |
| MT1998-21 | OTHER | None | None |