treatment of burkitt lymphoma/leukemia and b large cell nhl

Conditions: Non-Hodgkin Lymphoma; Acute Lymphoblastic Leukemia, Mature B-Cell

Summary: this is a pilot study to demonstrate that the modified lmb-89 treatment regimen for children with newly diagnosed small noncleaved cell nhl, large cell nhl (b-cell), and b-cell acute lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.

group a: resected stage i and resected abdominal stage ii subjects will receive two courses (3 weeks apart) of copad as follows: cyclophosphamide (ctx) 500 mg/m2/day (divided q12 hrs) iv day 1, 2, 3 vincristine (vcr) 2 mg/m2 (max 2.0 mg) iv day 1, 6 prednisone 60 mg/m2/d (divided bid) po day 1-5 adriamycin 60 mg/m2 over 6 hrs iv day 1 gcsf 5 mcg/kg/day sq will be given once a day starting on day 7 until blood counts recover. group b: other stage ii, stage iii, stage iv or b-all m blast \<70%; no cns involvement. treatment pre-induction subjects in group b will receive one week of treatment of cop as follows: ctx 300 mg/m2 iv day 1; vcr 1 mg/m2 (max 2.0 mg) iv day 1; prednisone 60 mg/m2/day (divided bid) po day 1-7; methotrexate (mtx) and hydrocortisone (hc) into the spinal fluid (it), each age adjusted, day 1; induction -copadm x 2 (copad m3 #1 (starting day 8 cop if greater than or equal to 20% reduction in tumor size by day 7 cop; if \<20% then proceed to group c starting at copadm8 no. 1); copadm3 #1 vcr 2 mg/m2 (max 2 mg) iv day 1; high-dose (hd) mtx 3 gm/m2 iv (over 3 hrs) day 1; mtx and hc each age adjusted it day 2, 6 ctx 500 mg/m2/day (divided q12 hrs) iv day 2, 3, 4; adriamycin 60 mg/m2 over 6 hrs iv; day 2; prednisone 60 mg/m2 (divided bid) po day 1-5. g-csf 5 mcg/kg/day starting day 7 until counts recover. copadm3 #2 like copadm #1 (above) except: 1. ctx - double dose (1 gm/m2/day) (divided q12 hr) 2. vcr - second dose given on day 6 consolidation- cym x 2 courses hdmtx 3 gm/m2 (over 3 hr) iv day 1; mtx plus hc each age adjusted it day 2; cytarabine (ara-c) 100 mg/m2/day ci/iv (x 5 days) day 2-6; ara-c and hc each age adjusted it day 7. maintenance sequence 1 prednisone 60 mg/m2/d (divided bid) po day 1-5; hdmtx 3 gm/m2 (over 3 hr) iv day 1; mtx plus hc each age adjusted it day 2; ctx 500 mg/m2/day iv day 2, 3; adriamycin 60 mg/m2 (over 6 hrs) iv day 3; vcr 2 mg/m2 (max 2 mg) iv day 1. g-csf 5 mcg/kg/day starting day 6 until counts recover. group c: b-all with \>70% bm blasts; cns involvement, group b cop failures i.e., \<20% reduction treatment pre-induction subjects will receive one week of treatment of cop as follows: ctx 300 mg/m2 iv day 1 vcr 1 mg/m2 (max 2 mg) iv day 1 prednisone 60 mg/m2/d (divided) bid po day 1-7 mtx + hc + ara-c each age adjusted it day 1, 3, 5 leucovorin 15 mg/m2 q12 hr x 2 po day 2, 4 induction-copadm x 2 subjects will begin induction therapy the day after cop is finished as follows: copadm8#1 vcr 2 mg/m2 (max 2 mg) iv day 1; hd mtx 8 gm/m2 (over 4 hrs) iv day 1; mtx+hc+ara-c each age adjusted it day 1, 4, 6 (ommaya, day 1); ctx 500 mg/m2/day divided every 12 hours iv day 2, 3, 4; adriamycin 60 mg/m2 (over 6 hrs) iv day 2; prednisone 60 mg/m2/day (divided bid) po/iv day 1-5. g-csf 5 mcg/kg/day starting day 7 until counts recover. copadm8 #2 like copad m8 #1 except: 1. ctx-double dose (1 gm/m2/day) (divided q12hs) iv 2. vcr - 2nd dose given on day 6 consolidation - cyve x 2 courses ara-c 50 mg/m2/12 hrs ci/iv day 1-5; hd ara-c 3 gm/m2/day iv over 3 hours day 2-5; vp-16 200 mg/m2/day iv over 2 hours day 2-5. maintenance: subjects will receive four courses of chemotherapy during continuation. each course will use different chemotherapy drugs. sequence 1 prednisone 60 mg/m2/day (divided bid) po/iv day 1-5; hd mtx 8 gm/m2 (over 4 hrs) iv day 1; mtx+hc+ara-c each age adjusted it day 2 (ommaya, day 2) ctx 500 mg/m2 iv day 2, 3; adriamycin 60 mg/m2 (over 6 hrs) iv day 3; vcr 2 mg/m2 (max 2 mg) iv day 1. g-csf 5 mcg/kg/day starting day 7 until counts recover. sequence 2 ara-c 100 mg/m2/day (divided q12 hrs) sq day 1-5; vp-16 150 mg/m2/day (over 2 hrs) iv days 1-3; g-csf 5 micro g/kg sq days 6 until counts recovery; mtx+hc+ara-c each age adjusted it day 1 (cns positive, only) ommaya day 1 (cns positive, only) sequence 3 prednisone 60 mg/m2/day (divided bid) po day 1-5; ctx 500 mg/m2/day iv day 1, 2; adriamycin 60 mg/m2 (over 6 hrs) iv day 2; vcr 2 mg/m2 (max 2 mg) iv day 1; g-csf 5 mcg/kg sq starting day 6 until counts recover; mtx+hc+ara-c each age adjusted it day 1 (cns positive, only) ommaya day 1 (cns positive, only). sequence 4 ara-c 100 mg/m2/day (divided q12 hrs) sq day 1-5; vp-16 150 mg/m2/day (over 2 hrs) iv days 1-3; g-csf 5 mcg/kg sq days 6 until counts recover; mtx+hc+ara-c each age adjusted it day 1 (cns positive, only) ommaya day 1 (cns positive, only) intrathecal (it) treatment doses and volume are as follows: \< than 1 year, mtx 8 mg, hc 8 mg, ara c 15 mg, volume 8 ml; age 12-23 mo, mtx 10 mg, hc 10 mg, ara c 20 mg, volume 10 ml; age 24-35 mo, mtx 12 mg, hc 12 mg, ara c 25 mg, volume 12 ml; age ≥3 yr, mtx 15 mg, hc 15 mg, ara c 30 mg. volume 15 ml ommaya reservoir treatment (cns positive only) age ≥3 yr, mtx 6 mg, hc 15 mg, ara c 50 mg/m2 (50 mg max) volume 3 ml

Eligibility criteria:
inclusion criteria: * subject must be previously untreated, except for steroids. * subject must be less than or equal to 18 years of age. * subject must have a histologic diagnosis of small noncleaved cell (sncc) nhl or large cell nhl (b-cell), or b-cell acute lymphocytic leukemia. exclusion criteria: * previously treated disease

Keywords: mature b-cell leukemia non-hodgkin lymphoma burkitt's lymphoma small noncleaved cell non hodgkin lymphoma large cell lymphoma