A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC# 731636, IND#) in Children With CD30+ Recurrent Anaplastic Large Cell Lymphoma
I. Define and describe the toxicities of monoclonal antibody SGN-30 alone (window) and in
combination with ifosfamide, carboplatin, and etoposide (ICE) in pediatric patients with
CD30-positive recurrent anaplastic large cell lymphoma.
II. Define, preliminarily, the antitumor activity of monoclonal antibody SGN-30 alone
(window) and in combination with ICE in these patients.
I. Characterize the pharmacokinetics of monoclonal antibody SGN-30 in these patients.
II. Characterize the soluble CD30 concentrations at time of relapse in these patients.
III. Characterize the development of human antichimeric antibodies in these patients.
IV. Measure minimal residual disease in these patients.
OUTLINE: This is a multicenter, pilot, phase I, dose-finding study of monoclonal antibody
SGN-30 followed by a phase II study.
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).
NOTE: **Patients planning to undergo bone marrow transplantation (BMT) receive 2 courses of
ICE only and then undergo BMT off study.
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.
After completion of study treatment, patients are followed periodically for 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of toxicities of SGN-30 alone and in combination with ICE using the National Cancer Institute Common Terminology Criteria for Adverse Events v. 3.0
Weekly for up to 23 weeks
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|