Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002835
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Prospective Study of Early Intensification Versus Alternating Triple Therapy for Patients With Poor Prognosis Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-11
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of early intensification vs alternating triple chemotherapy in patients with intermediate-grade or immunoblastic lymphoma with poor prognostic features
Compare in a prospective manner the costbenefit ratio of these regimens in these patients
Determine the value of monitoring minimal residual disease detection via in vitro culture methods and polymerase chain reaction analysis of peripheral stem cell apheresis products and by longitudinal monitoring of blood and bone marrow samples in these patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to tumor score 3 or 4 vs 5 or 6
During the first course of induction patients receive IDSHAP comprising idarubicin IDA and cisplatin IV continuously on days 1-4 cytarabine ARA-C IV over 2 hours on day 5 and methylprednisolone MePRDL IV over 15 minutes on days 1-5 During the second course of induction patients receive MBIDCOS comprising vincristine bleomycin and cyclophosphamide IV over 15 minutes on day 1 IDA IV continuously and MePRDL IV over 15 minutes on days 1-3 methotrexate MTX IV over 2 hours on day 10 and oral leucovorin calcium every 6 hours on days 11 and 12 Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease after induction are randomized to 1 of 2 treatment arms
Arm I
Patients receive the following 3 courses of early intensification
First course Patients receive ifosfamide IFF IV continuously and etoposide VP-16 IV over 2 hours every 12 hours on days 1-3 Filgrastim G-CSF is administered subcutaneously SC beginning on day 5 and continuing until blood counts recover and then autologous peripheral blood stem cells PBSC are harvested selected for CD34 positive cells and purged in vitro If more than 5 of the WBC contains lymphoma cells after induction then 2 courses of IFF and VP-16 are administered before PBSC harvest
Second course Patients receive IFF IV continuously on days 1-3 mitoxantrone DHAD IV on day 1 and G-CSF SC as in the first course
Third course Patients receive carmustine IV over 1 hour on day -6 ARA-C and VP-16 IV every 12 hours on days -5 to -2 and melphalan IV on day -1 PBSC are reinfused on day 0 G-CSF is administered SC beginning on day 0 and continuing until blood counts recover Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II
Patients receive IDSHAP during courses 2 and 5 MBIDCOS during courses 3 and 6 and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1 4 and 7 Each course lasts 4 weeks in the absence of disease progression or unacceptable toxicity
Patients with residual disease after completion of arm I or II treatment undergo radiotherapy to areas of bulk disease if feasible Patients on both arms with meningeal involvement receive ARA-C intrathecally IT alternated with MTX every other day until 1 week after clearing of CNS disease and then 2 IT injections during every course of chemotherapy thereafter Patients with divergent histology who achieve complete response after completion of arm I or II treatment receive interferon alfa 3 times a week for 1 year
Patients are followed at 1 month every 3 months for 1 year every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A maximum of 136 patients will be accrued for this study within 4 years
Compare the efficacy of early intensification vs alternating triple chemotherapy in patients with intermediate-grade or immunoblastic lymphoma with poor prognostic features
Compare in a prospective manner the costbenefit ratio of these regimens in these patients
Determine the value of monitoring minimal residual disease detection via in vitro culture methods and polymerase chain reaction analysis of peripheral stem cell apheresis products and by longitudinal monitoring of blood and bone marrow samples in these patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to tumor score 3 or 4 vs 5 or 6
During the first course of induction patients receive IDSHAP comprising idarubicin IDA and cisplatin IV continuously on days 1-4 cytarabine ARA-C IV over 2 hours on day 5 and methylprednisolone MePRDL IV over 15 minutes on days 1-5 During the second course of induction patients receive MBIDCOS comprising vincristine bleomycin and cyclophosphamide IV over 15 minutes on day 1 IDA IV continuously and MePRDL IV over 15 minutes on days 1-3 methotrexate MTX IV over 2 hours on day 10 and oral leucovorin calcium every 6 hours on days 11 and 12 Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity
Patients with stable or responding disease after induction are randomized to 1 of 2 treatment arms
Arm I
Patients receive the following 3 courses of early intensification
First course Patients receive ifosfamide IFF IV continuously and etoposide VP-16 IV over 2 hours every 12 hours on days 1-3 Filgrastim G-CSF is administered subcutaneously SC beginning on day 5 and continuing until blood counts recover and then autologous peripheral blood stem cells PBSC are harvested selected for CD34 positive cells and purged in vitro If more than 5 of the WBC contains lymphoma cells after induction then 2 courses of IFF and VP-16 are administered before PBSC harvest
Second course Patients receive IFF IV continuously on days 1-3 mitoxantrone DHAD IV on day 1 and G-CSF SC as in the first course
Third course Patients receive carmustine IV over 1 hour on day -6 ARA-C and VP-16 IV every 12 hours on days -5 to -2 and melphalan IV on day -1 PBSC are reinfused on day 0 G-CSF is administered SC beginning on day 0 and continuing until blood counts recover Each course lasts 3 weeks in the absence of disease progression or unacceptable toxicity
Arm II
Patients receive IDSHAP during courses 2 and 5 MBIDCOS during courses 3 and 6 and IFF and VP-16 IV over 1 hour on days 1-3 and DHAD IV over 15 minutes on day 1 during courses 1 4 and 7 Each course lasts 4 weeks in the absence of disease progression or unacceptable toxicity
Patients with residual disease after completion of arm I or II treatment undergo radiotherapy to areas of bulk disease if feasible Patients on both arms with meningeal involvement receive ARA-C intrathecally IT alternated with MTX every other day until 1 week after clearing of CNS disease and then 2 IT injections during every course of chemotherapy thereafter Patients with divergent histology who achieve complete response after completion of arm I or II treatment receive interferon alfa 3 times a week for 1 year
Patients are followed at 1 month every 3 months for 1 year every 6 months for 1 year and then annually for 2 years
PROJECTED ACCRUAL A maximum of 136 patients will be accrued for this study 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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-DM-95121 | OTHER | None | None |
| NCI-V96-1010 | None | None | None |
| CDR0000065044 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |