Ifosfamide, Carboplatin, Etoposide, and SGN-30 in Treating Young Patients With Recurrent Anaplastic Large Cell Lymphoma
Anaplastic Large Cell Lymphoma, Recurrent Childhood Anaplastic Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Anaplastic Large Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed anaplastic large cell lymphoma CD30-positive disease Must be in first or second relapse Measurable disease No CNS disease Karnofsky performance status (PS) 60-100% (> 16 years of age) OR Lansky PS 60-100% (≤ 16 years of age) Absolute neutrophil count ≥ 1,000/mm³ Platelet count ≥ 100,000/mm³ (transfusion independent) Platelet count ≥ 20,000/mm³ if bone marrow involvement (platelet transfusions allowed) Hemoglobin ≥ 8.0 g/dL (RBC transfusion independent, unless bone marrow involvement) Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months-11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT < 3 times ULN Albumin ≥ 2 g/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment No evidence of graft-vs-host disease No documented active infection requiring antibiotics No isolated bone recurrence Recovered from prior therapy At least 3 months since prior monoclonal antibody therapy At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) At least 7 days since prior hematopoietic growth factor therapy At least 3 months since prior biologic (antineoplastic) agents At least 2 weeks since prior local palliative radiotherapy (small port) At least 3 months since prior total-body irradiation, craniospinal radiotherapy, or radiotherapy to ≥ 50% of the pelvis At least 6 weeks since other prior substantial bone marrow irradiation At least 2 months since prior stem cell transplantation or rescue No prior monoclonal antibody SGN-30 Concurrent steroids allowed provided dose has been stable or decreasing for the past 7 days No concurrent immunosuppressive agents No concurrent dexamethasone as an antiemetic No other concurrent investigational drug or anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biological therapy
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (monoclonal antibody therapy, chemotherapy)
Patients receive monoclonal antibody SGN-30 IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV over 2 hours on days 1-3, carboplatin IV over 1 hour on day 1, and etoposide IV over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5). Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study.