exatecan mesylate in treating children with relapsed or refractory rhabdomyosarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.

objectives: * determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate. * determine the time to tumor progression in patients treated with this drug. * determine the median survival and survival at 6 and 12 months in patients treated with this drug. * assess pain in patients treated with this drug. * evaluate the quantitative and qualitative toxic effects of this drug in these patients. * evaluate the pharmacokinetics of this drug in these patients. outline: this is an open-label, nonrandomized, multicenter study. patients receive exatecan mesylate iv over 30 minutes on days 1-5. treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. patients who achieve a complete response (cr) receive 6 additional courses beyond cr. projected accrual: a total of 13-27 patients will be accrued for this study within 1 year.

Eligibility criteria:
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

Keywords: previously treated childhood rhabdomyosarcoma recurrent childhood rhabdomyosarcoma