Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma

Summary: 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.

Detailed description: 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.

Eligibility: 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:
  -  Medulloblastoma/PNET
  -  Ependymoma
  -  Brainstem glioma
  -  Other CNS 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
  -  Refractory to standard treatment and no curative therapy available
  -  Measurable disease
  PATIENT CHARACTERISTICS:
  Age:
  -  21 and under at time of original diagnosis
  Performance status:
  -  Karnofsky 50-100% in patients over 10 years of age
  -  Lansky 50-100% in patients age 10 and under
  Life expectancy:
  -  At least 8 weeks
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,000/mm^3
  -  Platelet count greater than 75,000/mm^3
  -  Hemoglobin greater than 8.0 g/dL
  Hepatic:
  -  Bilirubin normal for age
  -  SGPT less than 2.5 times upper limit of normal
  -  Amylase normal
  -  Lipase normal
  Renal:
  -  Creatinine normal for age OR
  -  Glomerular filtration rate at least 60 mL/min
  Other:
  -  No concurrent uncontrolled infection
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for 6 months after study participation
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Recovered from prior immunotherapy
  Chemotherapy:
  -  At least 6 weeks since prior nitrosourea and recovered
  -  Recovered from any other prior chemotherapy
  -  No more than two prior chemotherapy regimens
  Endocrine therapy:
  -  CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at least 2 weeks prior to study entry
  Radiotherapy:
  -  At least 6 weeks since prior extended radiotherapy and recovered
  -  No prior total body irradiation
  Surgery:
  -  Prior radiosurgery allowed
  Other:
  -  No concurrent use of the following foods or medications:
  -  Grapefruit juice
  -  Erythromycin
  -  Azithromycin
  -  Clarithromycin
  -  Rifampin and analogues
  -  Fluconazole
  -  Ketoconazole
  -  Itraconazole
  -  Cimetidine
  -  Cannabinoids (marijuana or dronabinol)
  -  Leukotriene inhibitors (e.g., zafirlukast and zileuton)
  -  No other concurrent anticancer or investigational agents

Relevance to patient case: not relevant