RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma.

Condition	Treatment or Intervention	Phase
adult soft tissue sarcoma gastrointestinal stromal tumor metastatic tumors of the Ewing''''s family tumors of the Ewing''''s family	Drug: FR901228  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the response rate in patients with metastatic or unresectable soft tissue sarcoma treated with FR901228.
• Determine the time to progression in patients treated with this drug.
• Determine the scope and extent of acute toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within approximately 1 year.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:
• Gastrointestinal stromal tumors
• Refractory to imatinib mesylate
• Desmoplastic small round cell tumors
• Clear cell sarcoma
• Extraskeletal osteosarcoma*
• Extraskeletal Ewing''''s sarcoma*
• Extraskeletal (myxoid) chondrosarcoma* NOTE: *Histologies typically associated with osseous primaries allowed provided the primary is extraskeletal
• Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis allowed)
• Metastatic or unresectable disease
• No standard curative therapy exists
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• WBC ≥ 3,000/mm^3
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal
• Bilirubin normal

Renal

• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• QTc < 500 msec
• No myocardial infarction within the past year
• No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
• No New York Heart Association class III or IV congestive heart failure
• No uncontrolled dysrhythmia
• No poorly controlled angina
• No other significant cardiac disease

Immunologic

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to FR901228
• No ongoing or active infection
• No iatrogenic immune deficiency or immune deficiency secondary to an underlying disorder

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Potassium ≥ 4.0 mmol/L
• Magnesium ≥ 2.0 mg/dL
• No other uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent anticancer biologic agents

Chemotherapy

• No more than 1 prior chemotherapy regimen for sarcoma
• Adjuvant chemotherapy preceding disease relapse is considered 1 prior chemotherapy regimen
• No prior FR901228
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No prior cumulative doxorubicin dose > 500 mg/m^2
• No other concurrent anticancer chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy
• No concurrent anticancer radiotherapy

Surgery

• At least 4 weeks since prior surgery
• No prior organ transplantation

Other

• Recovered from all prior therapy
• No concurrent medications that cause QTc prolongation
• No concurrent combination highly active anti-retroviral therapy for HIV-positive patients
• No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
• No other concurrent investigational agents
• No other concurrent anticancer agents

Please refer to this study by ClinicalTrials.gov identifier  NCT00112463

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States; Recruiting
Georgia
      Regional Radiation Oncology Center at Rome, Rome,  Georgia,  30165,  United States; Recruiting
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States; Recruiting
Kentucky
      Kentuckiana Cancer Institute, PLLC, Louisville,  Kentucky,  40202,  United States; Recruiting
North Carolina
      Alamance Cancer Center, Burlington,  North Carolina,  27216,  United States; Recruiting
      Brody School of Medicine at East Carolina University, Greenville,  North Carolina,  27858,  United States; Recruiting
      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  United States; Recruiting
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
      High Point Regional Hospital, High Point,  North Carolina,  27262,  United States; Recruiting
      Hugh Chatham Memorial Hospital, Elkin,  North Carolina,  28621,  United States; Recruiting
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States; Recruiting
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States; Recruiting
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
Virginia
      Cancer Center of the Piedmont, Incorporated, Danville,  Virginia,  24541,  United States; Recruiting
      Danville Hematology and Oncology, Incorporated, Danville,  Virginia,  24541,  United States; Recruiting

Study chairs or principal investigators

Paul D. Savage, MD,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000433042; CCCWFU-71103
Record last reviewed:  May 2005
Last Updated:  June 2, 2005
Record first received:  June 2, 2005
ClinicalTrials.gov Identifier:  NCT00112463
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07