Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: exatecan mesylate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exatecan mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma