Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma
A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 49 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma * No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site * Metastatic tumors of parameningeal sites eligible * Bidimensionally measurable disease * No positive cerebrospinal fluid cytology or multiple intracranial metastases * Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy: * Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy * Tumor that touches or displaces the spinal cord * Evidence of intracranial primary tumor extension * Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate * Requires emergency radiotherapy * Lab values are consistent with disseminated intravascular coagulation PATIENT CHARACTERISTICS: Age: * Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients) * 10 to 49 (embryonal histology patients) Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Absolute neutrophil count greater than 1,000/mm\^3\* * Platelet count greater than 150,000/mm\^3\* NOTE: \*Unless there is tumor involvement of bone marrow Hepatic: * Bilirubin less than 1.5 mg/dL * PT, PTT, and fibrinogen less than 1.5 times upper limit of normal Renal: * Creatinine less than 1.2 mg/dL Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior steroids allowed Radiotherapy: * See Disease Characteristics * No prior radiotherapy Surgery: * No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis
References
Publications (2)
- BACKGROUNDSoft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22. doi: 10.1200/JCO.2005.01.9497. PMID 16849756
- RESULTPappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH; Children's Oncology Group. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. doi: 10.1200/JCO.2006.07.1720. PMID 17264331