Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma (NCT00112463) | Clinical Trial Compass
CompletedPhase 2
Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma
40 participantsStarted 2005-01-07
Plain-language summary
This phase II trial studies how well depsipeptide (romidepsin) works in treating patients with metastatic or unresectable soft tissue sarcoma. Drugs used in chemotherapy, such as depsipeptide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:
* Gastrointestinal stromal tumors (GIST)
* Refractory to imatinib mesylate
* Desmoplastic small round cell tumors
* Clear cell sarcoma
* Extraskeletal osteosarcoma\*
* Extraskeletal Ewing's sarcoma\*
* Extraskeletal (myxoid) chondrosarcoma\*
* Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis) allowed
* Metastatic or unresectable disease
* No standard curative therapy exists
* Patients with GIST must have received and progressed on imatinib mesylate
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No known brain metastases
* Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
* Performance status - Karnofsky 50-100%
* More than 3 months
* White blood cells (WBC) ⥠3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ⤠2.5 times upper limit of normal (ULN)
* Bilirubin normal
* Creatinine \< 1.5 times ULN
* Creatinine clearance ≥ 60 mL/min
* QTc ≤ 480 msec
Exclusion Criteria:
* No cardiac abnormalities (e.g., congenital long QT syndrome)
* No myocardial infarction within the past year
* No history of coronary artery disease (e.g., angina Canadian Class II-IV or posit…
What they're measuring
1
Objective Tumor Response (Complete and Partial)
Timeframe: While on treatment - max of 16 months
2
Time to Progression
Timeframe: Until disease progression - max of 48 months
3
Toxicity as Assessed Using the Expanded Common Toxicity Criteria Version 3
Timeframe: During treatment (max of 16 months) and for 1 month following treatment