Clinical trial · Interventional
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
NCT00041249CI-TRIAL-00007469completedPhase 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 brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brostallicin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent * Stratum I * Malignant fibrous histiocytoma * Liposarcoma * Rhabdomyosarcoma * Synovial sarcoma * Malignant paraganglioma * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma including hemangiopericytoma * Malignant peripheral nerve sheath tumor * Unclassified sarcoma * Miscellaneous sarcoma * Stratum II * Gastrointestinal stromal tumor * Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression * The following sarcoma types are excluded: * Mixed mesodermal tumors of the uterus (and carcinosarcoma) * Chondrosarcoma * Malignant mesothelioma * Neuroblastoma * Osteosarcoma * Ewing's sarcoma * Embryonal rhabdomyosarcoma * At least one measurable lesion * Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease * Clinical evidence of progression within 6 weeks prior to study treatment * No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age: * Over 15 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * SGPT and SGOT no greater than 3 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance greater than 65 mL/min Cardiovascular: * No prior severe cardiovascular disease Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 6 months after study * No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix * No other severe medical illness * No psychosis PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic response modifiers or immunotherapy * No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF) Chemotherapy: * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy * No prior ecteinascidin 743 (stratum I) * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to sole measurable lesion * Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * No other concurrent anticancer therapy (approved or investigational) * No concurrent participation in any other clinical treatment study * No other concurrent investigational drugs
References
Publications (2)
- RESULTLeahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Jan;43(2):308-15. doi: 10.1016/j.ejca.2006.09.014. Epub 2006 Nov 13. PMID 17095209
- RESULTLeahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.