Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma

INCLUSION CRITERIA:

* Newly diagnosed, previously untreated histologically-proven rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma. Histology must be confirmed by a MSKCC pathologist.

Intermediate- or high-risk features as defined below:

* All patients with Stage 4 tumors (distant metastases).

Intermediate Risk:

* All patients with non-metastatic undifferentiated sarcoma or alveolar RMS or ectomesenchymoma with alveolar features (regardless of age, site, size, stage, or degree of initial surgical resection);
* All patients \< 1 year of age with non-metastatic embryonal RMS or ectomesenchymoma with embryonal features (regardless of site, stage, or degree of initial surgical resection).
* Patients ≥ 1 year of age with Stage 2 or 3 (unfavorable site \[see Appendix I\] and either size \> 5 cm, OR regional nodes positive, or both), Group III (gross residual disease post-biopsy or attempted resection) embryonal RMS or ectomesenchymoma with embryonal features
* Age: ≤ 50 years (inclusive) at the time of diagnosis.
* Biopsy or definitive surgery within 42 days of start of treatment.

Organ function:

* Normal renal function: Normal serum creatinine for age or creatinine clearance or nuclear GFR of ≥ 80 ml/min/1.73m2 (in the absence of obstructive hydronephrosis, e.g., from pelvic or bladder/prostate tumor).
* Normal liver function: Total bilirubin, SGOT/SGPT \< 2.5 times the upper limit of normal (in the absence of hepatic involvement by tumor)
* Normal cardiac function: echocardiogram shortening fraction ≥ 28% or resting left ventricular ejection fraction (LVEF) ≥ 50% on Technetium-99m pertechnetate radionuclide cineangiography (MUGA)
* Normal hematologic function: absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 gm/dL, and platelet count ≥ 100,000/μL (in the absence of bone marrow infiltration by tumor or the presence of disseminated intravascular coagulation).
* Measurable disease is not required.
* Patients must consent to an indwelling central venous catheter.
* Sexually active patients of childbearing potential must be willing to use an effective method of contraception.
* Patient or guardian must be capable of providing informed consent.

SUBJECT EXCLUSION CRITERIA:

* Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of threatened airway or cord compromise).
* Pregnant or breast feeding females because the chemotherapy administered on this trial could have a detrimental effect on the developing fetus or newborn.