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

Running, not enrolling · Phase 2

Conditions studied: Sarcoma

In brief

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.

Key facts

Study ID

NCT00077285

Run by

Memorial Sloan Kettering Cancer Center

People needed

65

Starts

2003-10-01

Expected to finish

2027-10-01

Last updated by the study team

2026-05-22

Who can join

Age: any, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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