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A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

A Trial of CCI-779 in Patients With Soft Tissue Sarcoma.


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 6 months (6 courses)

Safety Issue:

No

Principal Investigator

Scott Okuno

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02809

NCT ID:

NCT00087074

Start Date:

June 2004

Completion Date:

Related Keywords:

  • 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
  • Sarcoma
  • Gastrointestinal Stromal Tumors

Name

Location

Mayo ClinicRochester, Minnesota  55905