Clinical trial · Interventional
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
NCT00055939CI-TRIAL-00006923completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent or resistant rhabdomyosarcoma
* Measurable disease
* The following are not considered measurable disease:
* Ascites
* Pleural effusion
* Lytic bone lesions
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* ECOG 0-2 (over 10 years old)
* Lansky 60-100% (10 years old and under)
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 750/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 8.5 g/dL
Hepatic
* Bilirubin no greater than 2.0 mg/dL
* Albumin at least 2.8 g/dL
* AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal
* Creatinine no greater than 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No life threatening illness (unrelated to tumor) within the past 6 months
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No concurrent active serious infection
* No concurrent uncontrolled infection
* No overt psychosis or other incompetency that would preclude study compliance or giving informed consent
* No other concurrent noncancer-related illness that would preclude study participation or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior autologous bone marrow or stem cell transplantation
* No concurrent anticancer biologic therapy
Chemotherapy
* Recovered from prior adjuvant or systemic chemotherapy
* Prior topoisomerase I inhibitor therapy allowed
* No other concurrent anticancer chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve
* No concurrent anticancer radiotherapy
Surgery
* At least 4 weeks since prior major surgery
* Recovered from prior surgery
* No concurrent anticancer surgery
Other
* At least 28 days since prior investigational drugs (including analgesics or antiemetics)
* No more than 2 prior regimens for rhabdomyosarcoma
* No concurrent grapefruit-containing beverages or foods
* No other concurrent investigational drugs during and for 28 days after final dose of study drugReferences
Publications (0)
Data not yet available
No reference posted for this study.