Viewing Study NCT00096135



Ignite Creation Date: 2024-05-05 @ 11:37 AM
Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00096135
Status: COMPLETED
Last Update Posted: 2017-03-21
First Post: 2004-11-09

Brief Title: Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Sponsor: Childrens Oncology Group
Organization: Childrens Oncology Group

Study Overview

Official Title: Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia ALL Initial CR1 18 Months
Status: COMPLETED
Status Verified Date: 2017-02
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 work in different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Giving combination chemotherapy together with radiation therapy may kill more cancer cells

PURPOSE This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS andor testes
Detailed Description: OBJECTIVES

Primary

Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse
Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse
Determine the toxicity of these regimens in these patients

Secondary

Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens
Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens
Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients
Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients

OUTLINE This is a pilot multicenter study All patients receive common induction consolidation re-induction and intensification chemotherapy Patients are stratified to maintenance therapy according to site of extramedullary relapse CNS vs testicular

Induction therapy weeks 1-4 Patients receive vincristine IV on days 1 8 15 and 22 oral dexamethasone twice daily on days 1-28 daunorubicin IV over 15 minutes on days 1 8 and 15 and intrathecal triple therapy ITT comprising methotrexate hydrocortisone and cytarabine on days 1 8 15 and 22

NOTE The total dose of anthracyclines on this study is capped at 450 mgm2 Once this dose is reached all subsequent doses of daunorubicin are omitted

NOTE Patients with isolated testicular relapse receive ITT on day 1 only

In addition to the above patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14 Patients with clinical signs of disease at the end of induction undergo testicular biopsy

Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36

Consolidation therapy weeks 5-10 Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly IM on days 2 and 23 Patients also receive filgrastim G-CSF subcutaneously SC beginning on days 3 and 24 and continuing until blood counts recover

Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy

Intensification I weeks 11-22 Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1 22 43 and 64 and oral mercaptopurine once daily on days 2-6 23-27 44-48 and 65-69 Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8 29 50 and 71 Patients receive ITT on days 15 36 57 and 78

NOTE Patients with isolated testicular relapse receive ITT on days 36 and 78 only

Reinduction therapy weeks 23-26 Patients receive vincristine IV on days 1 8 15 and 22 oral dexamethasone twice daily on days 1-7 and 15-21 and daunorubicin IV over 15 minutes on days 1 8 and 15
Intensification II weeks 27-50 Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 43-44 85-86 and 127-128 pegaspargase IM on days 2 44 86 and 128 ITT on days 22 64 106 and 148 high-dose methotrexate IV continuously over 24 hours on days 29 71 113 and 155 oral mercaptopurine on days 30-34 72-76 114-118 and 156-160 and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36 78 120 and 162 Patients also receive G-CSF SC beginning on days 3 45 87 and 129 and continuing until blood counts recover

NOTE Patients with isolated testicular relapse receive ITT on days 22 and 106 only

Chemotherapy and radiotherapy weeks 51-54 Patients receive oral dexamethasone twice daily on days 1-7 and 15-21 vincristine IV on days 1 8 and 15 and pegaspargase IM on days 1 and 15

Patients with isolated CNS relapse also undergo cranial radiotherapy once daily 5 days a week for a total of 12 fractions

Maintenance therapy for isolated CNS relapse weeks 55-104 Patients receive dexamethasone PO orIV twice daily on days 1-5 oral mercaptopurine once daily on days 1-42 methotrexate IM on days 1 8 15 22 29 and 36 and vincristine IV and cyclophosphamide IV over 1 hour on days 43 50 57 and 64 Treatment repeats every 10 weeks for 5 courses
Maintenance therapy for isolated testicular relapse

Weeks 55-74 Patients receive ITT on day 1 and dexamethasone mercaptopurine methotrexate vincristine and cyclophosphamide as in maintenance therapy for isolated CNS relapse Treatment repeats every 10 weeks for 2 courses
Weeks 75-106 Patients receive vincristine IV on day 1 dexamethasone orally or IV on days 1-5 oral mercaptopurine on days 1-28 and methotrexate IM on days 1 8 15 and 22 Treatment repeats every 28 days for 8 courses Patients also receive ITT on day 1 every 12 weeks for 3 doses

Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction consolidation intensification I reinduction intensification II and maintenance phases of therapy as isolated CNS relapse patients

All patients undergo neuropsychological assessment within 3 months after completion of induction therapy before cranial radiotherapy and at 2 years after completion of treatment

Patients are followed for survival

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
NCI-2011-01623 OTHER NCI Trial Identifier None
COG-AALL02P2 OTHER None None