Clinical trial · Interventional
Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors
NCT00025363CI-TRIAL-00008981completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alveolar Childhood Rhabdomyosarcoma | Childhood Alveolar Rhabdomyosarcoma | ALIAS | 0.90 |
| Embryonal-botryoid Childhood Rhabdomyosarcoma | — | UNRESOLVED | — |
| Embryonal Childhood Rhabdomyosarcoma | Childhood Embryonal Rhabdomyosarcoma | ALIAS | 0.90 |
| Previously Treated Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: vincristine sulfate
- Drug: irinotecan hydrochloride
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: ifosfamide
- Drug: etoposide
- Drug: tirapazamine
- Biological: filgrastim
- Biological: sargramostim
- Other: pharmacological study
- Other: pharmacogenomic studies
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 1 hour on days 1-5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
* SGPT less than 2.5 times normal
* Creatinine no greater than 1.5 times normal
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
* Shortening fraction at least 27% by echocardiogram
* Ejection fraction at least 50% by MUGA
* No prior ischemic heart disease
* Seizure disorder allowed if well controlled by anticonvulsants
* No CNS toxicity greater than grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior myeloablative therapy with stem cell transplantation
* At least 1 week since prior antineoplastic biologic agent
* At least 1 week since prior growth factor(s)
* Recovered from prior immunotherapy
* No concurrent immunomodulating agents
* See Disease Characteristics
* See Biologic therapy
* No more than 1 prior chemotherapy regimen
* No prior doxorubicin or daunorubicin
* At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No other concurrent anticancer chemotherapy
* Concurrent corticosteroid therapy allowed
* At least 2 weeks since prior small-port radiotherapy.
* At least 6 months since prior radiotherapy to 50% or more of pelvis
* At least 6 weeks since other prior substantial radiotherapy to bone marrow
* Recovered from prior radiotherapy
* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated
* No concurrent intensity-modulated radiotherapyReferences
Publications (0)
Data not yet available
No reference posted for this study.