Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002657
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Sequential Modification of Immunosuppression Interferon Alpha and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation
Status:
COMPLETED
Status Verified Date:
2013-01
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 Reducing the amount of drugs used to prevent transplant rejection may help a persons body kill tumor cells Giving biological therapy such as interferon alfa which may interfere with the growth of cancer cells or combination chemotherapy which uses different ways to stop tumor cells from dividing so they stop growing or die may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of reducing immunosuppression and giving interferon alfa and combination chemotherapy in treating patients who have malignant tumors that develop after organ transplant
PURPOSE Phase II trial to study the effectiveness of reducing immunosuppression and giving interferon alfa and combination chemotherapy in treating patients who have malignant tumors that develop after organ transplant
Detailed Description:
OBJECTIVES I Evaluate the complete remission rate and survival of patients with lymphoproliferation following organ transplantation treated with a defined sequential approach modification of immunosuppression with surgery or limited radiotherapy for an isolated site of disease interferon alfa and chemotherapy ProMACE-CytaBOM cyclophosphamide doxorubicin etoposide prednisone cytarabine bleomycin vincristine methotrexate
OUTLINE All patients receive modification of immunocompetence unless rejection is present at outset These patients proceed directly to interferon treatment Group 1 see Disease Characteristics Patients receive reduced doses of their current immunosuppressive therapy for 10 days Group 2 Patients receive reduced doses of some of their current immunosuppressive therapy and discontinue some of the other therapy for 14 days Immunosuppressive therapy then resumes on day 15 Immunosuppressive therapy continues throughout other therapy unless otherwise noted Some patients may then undergo surgery or radiotherapy Interferon therapy Patients receive interferon alfa IFNA subcutaneously or intramuscularly on days 1-28 for a maximum of 3 courses Patients then receive maintenance therapy with IFNA 3 days a week for 4 weeks for up to 6 courses Chemotherapy ProMACE-CytaBOM Immunosuppressive therapy is stopped on days 1-20 Patients receive cyclophosphamide IV doxorubicin IV and etoposide IV over 60 minutes on day 1 oral prednisone on days 1-14 and cytarabine IV bleomycin IV vincristine IV and methotrexate IV on day 8 Treatment is repeated every 21 days for up to 6 courses Patients with positive CSF cytology receive intrathecal methotrexate or cytarabine on days 1 3 5 7 and 14 Some patients may continue this therapy on day 21 then every 3 weeks for 5 doses or may receive cranial irradiation Patients are followed monthly for 1 year every 2 months for 1 year every 4 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 4-5 years
OUTLINE All patients receive modification of immunocompetence unless rejection is present at outset These patients proceed directly to interferon treatment Group 1 see Disease Characteristics Patients receive reduced doses of their current immunosuppressive therapy for 10 days Group 2 Patients receive reduced doses of some of their current immunosuppressive therapy and discontinue some of the other therapy for 14 days Immunosuppressive therapy then resumes on day 15 Immunosuppressive therapy continues throughout other therapy unless otherwise noted Some patients may then undergo surgery or radiotherapy Interferon therapy Patients receive interferon alfa IFNA subcutaneously or intramuscularly on days 1-28 for a maximum of 3 courses Patients then receive maintenance therapy with IFNA 3 days a week for 4 weeks for up to 6 courses Chemotherapy ProMACE-CytaBOM Immunosuppressive therapy is stopped on days 1-20 Patients receive cyclophosphamide IV doxorubicin IV and etoposide IV over 60 minutes on day 1 oral prednisone on days 1-14 and cytarabine IV bleomycin IV vincristine IV and methotrexate IV on day 8 Treatment is repeated every 21 days for up to 6 courses Patients with positive CSF cytology receive intrathecal methotrexate or cytarabine on days 1 3 5 7 and 14 Some patients may continue this therapy on day 21 then every 3 weeks for 5 doses or may receive cranial irradiation Patients are followed monthly for 1 year every 2 months for 1 year every 4 months for 1 year then every 6 months thereafter
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study within 4-5 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 |
|---|---|---|---|
| U10CA032102 | NIH | ECOG | httpsreporternihgovquickSearchU10CA032102 |
| E-S9239 | OTHER | None | None |
| SWOG-9239 | OTHER | None | None |