Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003217
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkins Lymphoma or Acute Lymphoblastic Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage IIIIV Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-07
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 more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkins lymphoma or acute lymphoblastic leukemia
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkins lymphoma or acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES I Evaluate the feasibility and toxicity of dose intensification of methotrexate and cyclophosphamide in patients with stage III or IV small noncleaved cell non-Hodgkins lymphoma or B cell acute lymphoblastic leukemia II Estimate the response rate and survival of these patients after this therapy
OUTLINE This is a two-stage study Patients will receive cytarabine either by continuous infusion first stage or bolus injection second stage Patients are stratified by disease stage III non-Hodgkins lymphoma NHL vs stage IV NHL vs stage B acute lymphoblastic leukemia Therapy for all patients consists of alternating courses of A and B Patients with stage III disease receive 4 courses of chemotherapy ABAB while those with stage IV disease and B cell acute lymphoblastic leukemia receive 6 chemotherapy courses ABABAB Course A - Induction Patients receive intrathecal methotrexate IT MTX and intrathecal cytarabine IT Ara-C on days 1 4 and 11 Dexamethasone is administered by IV or orally twice a day on days 1-5 Cyclophosphamide IV is administered every 12 hours on days 1-3 Doxorubicin IV is administered over 15 minutes beginning 12 hours after the beginning of the 6th dose of cyclophosphamide day 4 At the same time vincristine IV is administered then repeated on day 11 Patients begin filgrastim granulocyte colony-stimulating factor G-CSF subcutaneously or IV over 30 minutes on day 5 Course B - Induction The first 10 patients enrolled receive cytarabine by continuous infusion while the second 10 patients enrolled receive cytarabine by bolus IV Patients begin treatment on day 18 and receive methotrexate IV over 24 hours plus IT MTX during hour 1 Dexamethasone is administered by IV or orally twice a day on days 1-5 After completing the 24 hour IV MTX infusion patients begin cytarabine by continuous infusion over 48 hours or bolus IV every 12 hours for 4 doses Patients receive G-CSF subcutaneously or IV over 30 minutes beginning on day 22 Patients are assessed for remission status before day 36 Course A - Consolidation Patients receive dexamethasone IV or orally twice a day on days 1-5 IT MTX and IT Ara-C are administered on days 1 and 4 Cyclophosphamide is administered as during Induction with vincristine IV and doxorubicin IV over 15 minutes 12 hours later Vincristine repeats 1 week later G-CSF administration begins on day 5 Course B - Consolidation Therapy begins on day 22 with dexamethasone administered as previously Methotrexate infusion and IT MTX are administered as in Course B - Induction as is cytarabine either as a continuous infusion or bolus IV G-CSF is also administered as previously Patients are followed monthly for the first 6 months every 2 months for the next 6 months then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 16 months
OUTLINE This is a two-stage study Patients will receive cytarabine either by continuous infusion first stage or bolus injection second stage Patients are stratified by disease stage III non-Hodgkins lymphoma NHL vs stage IV NHL vs stage B acute lymphoblastic leukemia Therapy for all patients consists of alternating courses of A and B Patients with stage III disease receive 4 courses of chemotherapy ABAB while those with stage IV disease and B cell acute lymphoblastic leukemia receive 6 chemotherapy courses ABABAB Course A - Induction Patients receive intrathecal methotrexate IT MTX and intrathecal cytarabine IT Ara-C on days 1 4 and 11 Dexamethasone is administered by IV or orally twice a day on days 1-5 Cyclophosphamide IV is administered every 12 hours on days 1-3 Doxorubicin IV is administered over 15 minutes beginning 12 hours after the beginning of the 6th dose of cyclophosphamide day 4 At the same time vincristine IV is administered then repeated on day 11 Patients begin filgrastim granulocyte colony-stimulating factor G-CSF subcutaneously or IV over 30 minutes on day 5 Course B - Induction The first 10 patients enrolled receive cytarabine by continuous infusion while the second 10 patients enrolled receive cytarabine by bolus IV Patients begin treatment on day 18 and receive methotrexate IV over 24 hours plus IT MTX during hour 1 Dexamethasone is administered by IV or orally twice a day on days 1-5 After completing the 24 hour IV MTX infusion patients begin cytarabine by continuous infusion over 48 hours or bolus IV every 12 hours for 4 doses Patients receive G-CSF subcutaneously or IV over 30 minutes beginning on day 22 Patients are assessed for remission status before day 36 Course A - Consolidation Patients receive dexamethasone IV or orally twice a day on days 1-5 IT MTX and IT Ara-C are administered on days 1 and 4 Cyclophosphamide is administered as during Induction with vincristine IV and doxorubicin IV over 15 minutes 12 hours later Vincristine repeats 1 week later G-CSF administration begins on day 5 Course B - Consolidation Therapy begins on day 22 with dexamethasone administered as previously Methotrexate infusion and IT MTX are administered as in Course B - Induction as is cytarabine either as a continuous infusion or bolus IV G-CSF is also administered as previously Patients are followed monthly for the first 6 months every 2 months for the next 6 months then every 6 months for 3 years then annually thereafter
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 16 months
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 |
|---|---|---|---|
| CDR0000066078 | OTHER | Clinical Trialsgov | None |
| POG-9517 | OTHER | None | None |