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CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor

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ClinicalTrials.gov Identifier: NCT00087074
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This phase II trial is studying how well CCI-779 works in treating patients with soft tissue sarcoma or gastrointestinal stromal tumor. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor 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 Drug: temsirolimus Other: laboratory biomarker analysis Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the antitumor activity of CCI-779 in this patient population.

SECONDARY OBJECTIVES:

I. To assess the following in patients with soft tissue sarcomas and following treatment with CCI-779: duration of response, time to progression, survival.

TERTIARY OBJECTIVES:

I. To describe and correlate the following with patient characteristics and outcome in this patient population and following treatment with CCI-779: relative levels of 4EBP1 to eIF4E, phospho 4EBP1, total and phospho ribosomal S6 on pretreatment tumor tissue, expression levels of EGFR, activated EGFR, Her2, c-Myc, phospho Akt, total Akt, phospho-mTOR and total mTOR on pretreatment tumor tissue, drug induced inhibition of p70S6 kinase activity, and phosphorylation of S6 in PBMC, relative levels of serum sirolimus in post-treatment samples.

OUTLINE:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.
Study Start Date : June 2004
Actual Primary Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (temsirolimus)
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.
 Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

Other: laboratory biomarker analysis
Optional correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart [ Time Frame: Up to 6 months (6 courses) ]

Secondary Outcome Measures :
  1. Survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 5 years ]
    The distribution of survival time will be estimated using the method of Kaplan-Meier.

  2. Time to disease progression [ Time Frame: Time from registration to documentation of disease progression, assessed up to 5 years ]
    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

  3. Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented [ Time Frame: Up to 5 years ]
  4. Time to treatment failure [ Time Frame: Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologic confirmed soft tissue sarcoma
  • Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments
  • Absolute neutrophil count (ANC) >= 1,500/μL
  • Platelets (PLTS) >= 100,000/μL
  • Hgb >= 10.0 g/dL
  • Direct bilirubin =< 1.5 x ULN (upper limit normal)
  • AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
  • ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present
  • Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2
  • Baseline glucose levels
  • Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L)
  • Fasting triglycerides =< 400 mg/dL (4.56 mmol/L)
  • ECOG Performance Status (PS) 0, 1 or 2
  • Life expectancy >= 12 weeks
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

Exclusion Criteria:

  • Any of the following as this regimen may be harmful to a developing fetus or nursing child:

    • Pregnant women
    • Breast-feeding women
    • Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)

  • Any of the following:

    • Nitrosoureas or mitomycin =< 6 weeks prior to study entry
    • Other chemotherapy =< 4 weeks prior to study entry
    • Radiotherapy =< 4 weeks prior to study entry
    • Concurrent use of any other investigation agent
    • Adverse events due to agents administered =< 4 weeks prior to study entry
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known HIV-positive patients receiving combination anti-retroviral therapy

  • Prior chemotherapy for metastatic disease

    • Exceptions:

      • Patients with GIST who fail Gleevec are eligible
      • Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible

  • Known brain metastases

    • Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087074


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Scott Okuno Mayo Clinic
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087074    
Other Study ID Numbers: NCI-2012-02809
MC027B
N01CM17104 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Sarcoma
Gastrointestinal Stromal Tumors
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs