Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This randomized phase III trial is studying two different combination chemotherapy regimens
to compare how well they work when given together with radiation therapy in treating patients
with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine
sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination
chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known
which combination chemotherapy regimen is more effective when given together with radiation
therapy in treating patients with rhabdomyosarcoma.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Pediatric Cancer
Enrollment Eligibility
Inclusion Criteria:
- Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of
embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study
- Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology
review is required for all patients
- Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of
central pathology review results
- Patient must have Intermediate-risk RMS defined as:
- Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and
group III OR
- Alveolar RMS: stage 1-3 and group I-III
- Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all
patients >= 10 years of age with paratesticular tumors and for patients < 10 years
with clinically or radiographically involved lymph nodes (except when extensive lymph
node involvement, defined as two or more lymph nodes > 2 cm in dimension, is
identified by imaging studies)
- Regional lymph node sampling or sentinel lymph node procedure is required for
histologic evaluation in patients with extremity tumors
- Clinically or radiographically enlarged nodes should be sampled for histologic
evaluation
- Detection of metastasis by optional FDG PET (not required for study enrollment); FDG
PET may detect abnormalities suggestive of metastasis not identified by bone scan,
computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic
significance of FDG PET-detected abnormalities is not clear; FDG PET-detected
abnormalities MUST be confirmed to be metastases by an additional imaging modality
(such as magnetic resonance imaging [MRI] or CT) OR pathologic confirmation; unless
FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET
abnormalities will NOT be considered evidence of metastasis
- Patients must have a performance status of 0, 1, or 2; the Lansky performance score
should be used for patients < 16 years and the Karnofsky performance score for
patients >= 16 years
- Patients who have received prior chemotherapy (excluding steroids) or radiation
therapy, except for patients transferring from ARST0331 (low-risk study), are not
eligible
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
- 1 month to < 6 months: 0.4 mg/dL
- 6 months to < 1 year: 0.5 mg/dL
- 1 to < 2 years: 0.6 mg/dL
- 2 to < 6 years: 0.8 mgt/dL
- 6 to < 10 years: 1 mg/dL
- 10 to < 13 years: 1.2 mg/dL
- 13 to < 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females)
- >= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females)
- Patients with urinary tract obstruction by tumor must meet the renal function criteria
AND must have unimpeded urinary flow established via decompression of the obstructed
portion of the urinary tract
- Total bilirubin =< 1.5 x upper limit of normal for age
- Peripheral absolute neutrophil count (ANC) >= 750/uL
- Platelet count >= 75,000/uL (transfusion independent)
- No evidence of uncontrolled infection
- Patients must be able to undergo radiation therapy, if necessary, as specified in the
protocol
- Female patients of childbearing potential must have a negative pregnancy test
- Female patients who are breast feeding must agree to stop breast feeding
- Sexually active patients of childbearing potential must be willing to use effective
contraception during therapy and for at least 1 month after treatment is completed
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met