Status:
ACTIVE_NOT_RECRUITING
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 50 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with newly diagnosed intermediate- or high-risk rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and carboplat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00077285
Start Date
October 1 2003
End Date
October 1 2026
Last Update
November 4 2025
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065