Clinical trial · Interventional
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)
- 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 patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.
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:
* One of the following histologically confirmed diagnoses:
* Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor
* Desmoplastic small round cell tumor
* 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 of age)
* Lansky 60-100% (10 years of age 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
* AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Albumin at least 2.8 g/dL
Renal
* Creatinine less than 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active serious infection
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No overt psychosis or mental disability that would preclude informed consent
* No other life-threatening illness within the past 6 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 months since prior autologous bone marrow or stem cell transplantation
* No concurrent biologic therapy
Chemotherapy
* Recovered from prior systemic chemotherapy
* Prior topoisomerase I inhibitor therapy allowed
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy
* More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve
* No concurrent radiotherapy
Surgery
* At least 4 weeks since prior major surgery and recovered
* No concurrent surgery
Other
* More than 28 days since prior investigational drugs (including analgesics or antiemetics)
* No more than 2 prior treatment regimens for this disease
* No other investigational drugs during and for 28 days after study therapy
* No other concurrent anticancer therapy
* No concurrent grapefruit or grapefruit juiceReferences
Publications (0)
Data not yet available