Conditions: Liposarcoma Leiomyosarcoma Fibrosarcoma Malignant Fibrous Histiocytoma
Keywords: Sunitinib malate SUTENT SU011248 Soft tissue sarcoma Gastrointestinal stromal tumors (GIST) MFH Tyrosine kinase inhibitor Imatinib mesylate Phase II
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 48
Healthy volunteers: no

Brief summary:
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity.

All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

Detailed description:
This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment.

All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit.

Arms:
arm 1: Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks

Interventions: intervention 1: Sunitinib Malate (SU011248)
Intervention descriptions: intervention 1: For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.

Protocol document: