Overview
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-10-01
2022-10-01
Target enrollment:
0
0
Participant gender:
All
All
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 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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Memorial Sloan Kettering Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Camptothecin
Carboplatin
Cyclophosphamide
Dexrazoxane
Doxorubicin
Etoposide
Ifosfamide
Irinotecan
Liposomal doxorubicin
Razoxane
Vincristine
Criteria
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.