Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003631
Status:
COMPLETED
Last Update Posted:
2016-01-25
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
High-Dose Chemo-Radiotherapy for Patients With Primary Refractory and Relapsed Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2015-12
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with refractory or relapsed Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with refractory or relapsed Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Assess the efficacy of a high-dose chemoradiotherapy regimen in patients with refractory or relapsed Hodgkins lymphoma
OUTLINE Patients are stratified into 1 of 3 treatment arms 0-1 adverse prognostic factors vs 2 adverse prognostic factors vs 3 adverse prognostic factors
Arm I 0-1 adverse prognostic factors Patients receive ifosfamide by 24 hour infusion on day 2 Carboplatin is administered on day 2 Etoposide IV is administered once daily on days 1-3 Patients then receive filgrastim G-CSF subcutaneously or IV on days 5-12 Patients receive another course of ICE chemotherapy 2-3 weeks after the first course
Leukapheresis is performed once WBC reaches at least 3000mm3 and continues until enough peripheral blood stem cells are collected
Patients who have never received prior radiotherapy will receive accelerated hyperfractionated total lymphoid irradiation TLI twice a day for 5 days days -10 to -6 Cyclophosphamide IV is then administered on days -5 and 4 Etoposide IV is administered by continuous infusion over 4 days days -5 to -2
Patients who have had prior radiotherapy receive high dose chemotherapy Cyclophosphamide IV is administered on days -6 and -5 Etoposide IV is administered by continuous infusion over 4 days days -6 to -3 Carmustine IV is administered on day -2
Peripheral blood stem cells are infused 24-36 hours after high-dose chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Arm II 2 adverse prognostic factors Patients receive the first course of ICE as in Arm I
Apheresis is performed once WBC is greater than 3000mm3 and continues until enough cells are collected The second course of ICE is then administered
Ifosfamide is administered by 48 hour continuous infusion on days 1-2 Carboplatin is administered on day 3 Etoposide IV is administered every 12 hours for 3 doses beginning on day 1 Patients receive G-CSF on days 5-14
Patients who have never received prior radiotherapy will receive accelerated hyperfractionated TLI for 5 days days -10 to -6 Cyclophosphamide IV is then administered every 12 hours on days -5 to -2 Etoposide IV is administered by continuous infusion over 4 days days -5 to -2
Patients who have had prior radiotherapy receive high-dose chemotherapy Cyclophosphamide IV is administered every 12 hours on days -6 to -3 Etoposide IV is administered by continuous infusion over 4 days days -6 to -3 Carmustine IV is administered on day -2
Peripheral blood stem cells are infused 24-36 hours after high dose chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Arm III 3 adverse prognostic factors Patients receive cyclophosphamide IV daily for 2 days then G-CSF beginning on day 4 until blood stem cells are collected
Patients then undergo apheresis until enough cells are collected
Patients receive high-dose chemotherapy Ifosfamide IV is administered for 1 hour Etoposide is administered by continuous infusion for 12 hours Carboplatin IV is administered for 1 hour Etoposide is again administered by continuous infusion for 12 hours Treatment is repeated daily for 5 days
Peripheral blood stem cells are reinfused 24-36 hours after the last dose of chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Patients who have never received prior radiation will now receive accelerated hyperfractionated TLI twice daily for 5 days Patients receive a second course of high dose chemotherapy 45-90 days after reinfusion of cells Etoposide IV and cytarabine IV are administered every 12 hours for 4 days days -6 to -3 Melphalan IV is administered on day -2
Patients who have received prior radiation therapy receive a second course of high-dose chemotherapy Carmustine IV is administered on day -7 Etoposide IV and cytarabine IV are administered every 12 hours for 4 days days -6 to -3 Melphalan IV is administered on day -2
Peripheral blood stem cells are reinfused 24-48 hours after completion of second course chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Patients are followed every 3 months for the first 2 years every 4 months during years 3-5 and every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 80 patients within 4 years
Assess the efficacy of a high-dose chemoradiotherapy regimen in patients with refractory or relapsed Hodgkins lymphoma
OUTLINE Patients are stratified into 1 of 3 treatment arms 0-1 adverse prognostic factors vs 2 adverse prognostic factors vs 3 adverse prognostic factors
Arm I 0-1 adverse prognostic factors Patients receive ifosfamide by 24 hour infusion on day 2 Carboplatin is administered on day 2 Etoposide IV is administered once daily on days 1-3 Patients then receive filgrastim G-CSF subcutaneously or IV on days 5-12 Patients receive another course of ICE chemotherapy 2-3 weeks after the first course
Leukapheresis is performed once WBC reaches at least 3000mm3 and continues until enough peripheral blood stem cells are collected
Patients who have never received prior radiotherapy will receive accelerated hyperfractionated total lymphoid irradiation TLI twice a day for 5 days days -10 to -6 Cyclophosphamide IV is then administered on days -5 and 4 Etoposide IV is administered by continuous infusion over 4 days days -5 to -2
Patients who have had prior radiotherapy receive high dose chemotherapy Cyclophosphamide IV is administered on days -6 and -5 Etoposide IV is administered by continuous infusion over 4 days days -6 to -3 Carmustine IV is administered on day -2
Peripheral blood stem cells are infused 24-36 hours after high-dose chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Arm II 2 adverse prognostic factors Patients receive the first course of ICE as in Arm I
Apheresis is performed once WBC is greater than 3000mm3 and continues until enough cells are collected The second course of ICE is then administered
Ifosfamide is administered by 48 hour continuous infusion on days 1-2 Carboplatin is administered on day 3 Etoposide IV is administered every 12 hours for 3 doses beginning on day 1 Patients receive G-CSF on days 5-14
Patients who have never received prior radiotherapy will receive accelerated hyperfractionated TLI for 5 days days -10 to -6 Cyclophosphamide IV is then administered every 12 hours on days -5 to -2 Etoposide IV is administered by continuous infusion over 4 days days -5 to -2
Patients who have had prior radiotherapy receive high-dose chemotherapy Cyclophosphamide IV is administered every 12 hours on days -6 to -3 Etoposide IV is administered by continuous infusion over 4 days days -6 to -3 Carmustine IV is administered on day -2
Peripheral blood stem cells are infused 24-36 hours after high dose chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Arm III 3 adverse prognostic factors Patients receive cyclophosphamide IV daily for 2 days then G-CSF beginning on day 4 until blood stem cells are collected
Patients then undergo apheresis until enough cells are collected
Patients receive high-dose chemotherapy Ifosfamide IV is administered for 1 hour Etoposide is administered by continuous infusion for 12 hours Carboplatin IV is administered for 1 hour Etoposide is again administered by continuous infusion for 12 hours Treatment is repeated daily for 5 days
Peripheral blood stem cells are reinfused 24-36 hours after the last dose of chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Patients who have never received prior radiation will now receive accelerated hyperfractionated TLI twice daily for 5 days Patients receive a second course of high dose chemotherapy 45-90 days after reinfusion of cells Etoposide IV and cytarabine IV are administered every 12 hours for 4 days days -6 to -3 Melphalan IV is administered on day -2
Patients who have received prior radiation therapy receive a second course of high-dose chemotherapy Carmustine IV is administered on day -7 Etoposide IV and cytarabine IV are administered every 12 hours for 4 days days -6 to -3 Melphalan IV is administered on day -2
Peripheral blood stem cells are reinfused 24-48 hours after completion of second course chemotherapy G-CSF is administered beginning on day 1 and continuing until blood counts recover
Patients are followed every 3 months for the first 2 years every 4 months during years 3-5 and every 6 months thereafter
PROJECTED ACCRUAL This study will accrue 80 patients within 4 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 |
|---|---|---|---|
| CDR0000066714 | REGISTRY | None | None |
| NCI-G98-1480 | Registry Identifier | PDQ Physician Data Query | None |