A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
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.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumors
Neuroblastoma
Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's sarcoma closed to accrual as of 5/19/03)
Osteosarcoma (closed to accrual as of 5/19/03)
Rhabdomyosarcoma
Other extracranial solid tumors
CNS/brain tumors:
Histological verification may be waived for brainstem glioma and classic optic glioma, but biopsy recommended OR
Histologically or cytologically proven non-Hodgkin's lymphoma
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No concurrent use of the following foods or medications:
No other concurrent anticancer or investigational agents
Birmingham, Alabama 35233, United States
Long Beach, California 90801-1428, United States
San Diego, California 92120, United States
San Francisco, California 94115, United States
Lexington, Kentucky 40536-0284, United States
Baltimore, Maryland 21201-1595, United States
Baltimore, Maryland 21231-2410, United States
Worcester, Massachusetts 01655, United States
Albuquerque, New Mexico 87131, United States
Brooklyn, New York 11203, United States
Stony Brook, New York 11790-7775, United States
Lackland Air Force Base, Texas 78236-5300, United States
St. John's, Newfoundland and Labrador A1B 3V6, Canada
San Juan, 00936-5067, Puerto Rico