Lymphoma Clinical Trial
Official title:
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
OBJECTIVES:
I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated
with rebeccamycin analogue.
II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these
patients.
III. Determine the toxicity of this drug in these patients. IV. Determine the
pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs
Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor
[PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs
non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified
according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs
other CNS tumors).
Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21
days for a total of 16 courses in the absence of disease progression or unacceptable
toxicity.
Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1
year, and then annually thereafter.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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