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

Inclusion 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