Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
Completed · Phase 2
Conditions studied: Alveolar Childhood Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Rhabdomyosarcoma
In brief
Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have rhabdomyosarcoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells
Key facts
- Study ID
- NCT00025363
- Run by
- National Cancer Institute (NCI)
- People needed
- 150
- Starts
- 2001-11-01
- Last updated by the study team
- 2013-01-17
Who can join
Age: any, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
- First relapse or first occurrence of disease progression
- Unfavorable-risk patients eligible for study window therapy with irinotecan and vincristine meeting the following criteria:
- Unfavorable risk defined by any of the following:
- Embryonal histology with stage I or group I at initial diagnosis with distant recurrence or with local or regional recurrence after prior cyclophosphamide
- Embryonal histology with initial stage II, III, or IV or group II, III, or IV with any relapse pattern
- Alveolar histology with any stage or group at initial diagnosis
- At least unidimensionally measurable disease
- No prior irinotecan
- Bone marrow must not be only site of relapse
- Unfavorable-risk patients ineligible for study window therapy with irinotecan meeting the following criteria:
- Either no measurable disease OR patient received prior irinotecan
- Bone marrow as only site of relapse allowed
- Favorable-risk patients meeting the following criteria:
- Initial botryoid histology (any stage, any group, or any pattern of relapse)
- Embryonal histology if either stage I or group I (with either local or regional recurrence)
- No prior cyclophosphamide
- No CNS metastases
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- At least 2 months
- Absolute neutrophil count at least 750/mm\^3
- Platelet count at least 75,000/mm\^3 (transfusion independent)
- Hemoglobin at least 10.0 g/dL (red blood cell transfusion allowed)
- Bilirubin no greater than 1.5 times normal
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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