Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003408
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
1999-11-01
Brief Title:
Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
Sponsor:
Cancer Treatment Centers of America
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Cytokine-Based Immunotherapy Following High-Dose Chemotherapy and Autologous Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2003-04
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining chemotherapy and peripheral stem cell transplantation with biological therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of biological therapy with sargramostim interleukin-2 and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer
PURPOSE Phase II trial to study the effectiveness of biological therapy with sargramostim interleukin-2 and interferon alfa following chemotherapy and peripheral stem cell transplantation in treating patients who have cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of therapy with sargramostim GM-CSF interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer
Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients
Determine the cellular response to this regimen in these patients
Assess progression free and overall survival rates in these patients
OUTLINE This is a dose escalation study of interleukin-2 and interferon alfa
Beginning 14 days after the autologous stem cell transplant patients receive daily subcutaneous injections of sargramostim GM-CSF on days 1-7 and daily intravenous interleukin-2 on days 3-7 followed by 1 week of rest Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest Treatment is repeated for four courses
Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity Intrapatient dose escalation occurs in courses 2-4 in the absence of dose limiting toxicity
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
Determine the feasibility of therapy with sargramostim GM-CSF interleukin-2 and interferon alfa following high dose chemotherapy and autologous stem cell rescue in patients with high risk cancer
Determine the effect of this regimen on long-term leukocyte and platelet recovery following high dose chemotherapy and stem cell rescue in these patients
Determine the cellular response to this regimen in these patients
Assess progression free and overall survival rates in these patients
OUTLINE This is a dose escalation study of interleukin-2 and interferon alfa
Beginning 14 days after the autologous stem cell transplant patients receive daily subcutaneous injections of sargramostim GM-CSF on days 1-7 and daily intravenous interleukin-2 on days 3-7 followed by 1 week of rest Patients then receive a subcutaneous injection of interferon alfa three times a week for 3 weeks followed by one more week of rest Treatment is repeated for four courses
Cohorts of 10 patients each receive escalating doses of interleukin-2 and interferon alfa until a maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 3 of 10 patients experience dose limiting toxicity Intrapatient dose escalation occurs in courses 2-4 in the absence of dose limiting toxicity
PROJECTED ACCRUAL A maximum of 40 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 |
|---|---|---|---|
| MRMC-CTCA-9801 | None | None | None |
| NCI-V98-1449 | None | None | None |