RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor.

Condition	Treatment or Intervention	Phase
recurrent adult soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma gastrointestinal stromal tumor	Drug: CCI-779  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the antitumor activity of CCI-779 in patients with soft tissue sarcoma or gastrointestinal stromal tumor.

Secondary

• Determine the duration of response in patients treated with this drug.
• Determine time to disease progression in patients treated with this drug.
• Determine survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 4-10 months.

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically and cytologically confirmed diagnosis of 1 of the following:
• Soft tissue sarcoma
• Gastrointestinal stromal tumor that has progressed OR is intolerant to imatinib mesylate
• Measurable disease
• At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• No known brain metastases
• Treated brain metastases allowed provided symptoms are stable for at least 1 month after prior treatment

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL

Hepatic

• ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Fasting serum cholesterol ≤ 350 mg/dL
• Fasting triglycerides ≤ 400 mg/dL
• No diabetes
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779
• No active or ongoing infection
• No concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• No concurrent prophylactic hematopoietic colony-stimulating factors

Chemotherapy

• Prior adjuvant/neoadjuvant chemotherapy allowed
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No prior chemotherapy for metastatic disease except for patients with gastrointestinal stromal tumors who failed imatinib mesylate

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer agents or therapies
• No other concurrent investigational agents

District of Columbia
      Howard University Cancer Center at Howard University Hospital, Washington,  District of Columbia,  20060,  United States; Recruiting
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States; Recruiting
Missouri
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States; Recruiting
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting

Study chairs or principal investigators

Scott Okuno, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000372912; MAYO-MC027B; NCI-6156; NCT00087074
Record last reviewed:  July 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087074
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08