Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed recurrent or resistant rhabdomyosarcoma
• Measurable disease
• * The following are not considered measurable disease:
• * Ascites
• * Pleural effusion
• * Lytic bone lesions
• No symptomatic brain metastases
• PATIENT CHARACTERISTICS:
• Age
• Any age
• Performance status
• ECOG 0-2 (over 10 years old)
• Lansky 60-100% (10 years old and under)
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Absolute neutrophil count at least 750/mm\^3
• Platelet count at least 75,000/mm\^3
• Hemoglobin at least 8.5 g/dL
• Hepatic
• Bilirubin no greater than 2.0 mg/dL
• Albumin at least 2.8 g/dL
• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• Renal
• Creatinine no greater than 1.5 times ULN
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No life threatening illness (unrelated to tumor) within the past 6 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No concurrent active serious infection
• No concurrent uncontrolled infection
• No overt psychosis or other incompetency that would preclude study compliance or giving informed consent
• No other concurrent noncancer-related illness that would preclude study participation or follow-up
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• At least 3 months since prior autologous bone marrow or stem cell transplantation
• No concurrent anticancer biologic therapy
• Chemotherapy
• Recovered from prior adjuvant or systemic chemotherapy
• Prior topoisomerase I inhibitor therapy allowed
• No other concurrent anticancer chemotherapy
• Endocrine therapy
• Not specified
• Radiotherapy
• More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve
• No concurrent anticancer radiotherapy
• Surgery
• At least 4 weeks since prior major surgery
• Recovered from prior surgery
• No concurrent anticancer surgery
• Other
• At least 28 days since prior investigational drugs (including analgesics or antiemetics)
• No more than 2 prior regimens for rhabdomyosarcoma
• No concurrent grapefruit-containing beverages or foods
• No other concurrent investigational drugs during and for 28 days after final dose of study drug