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CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087074
  Purpose

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 Intervention Phase
Gastrointestinal Stromal Tumor
Sarcoma
Drug: temsirolimus
Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Trial Of CCI-779 In Patients With Soft Tissue Sarcoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate by RECIST evaluations after second course [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Study Start Date: June 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087074

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Scott Okuno, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000372912, MAYO-MC027B, NCI-6156
Study First Received: July 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00087074  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Malignant mesenchymal tumor
Sarcoma
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Soft tissue sarcomas
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009