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

NCT00087074 | Completed Phase 2

• 3 other identifiers: NCI-2012-02809MC027BN01CM17104
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  Up to 6 months (6 courses)

Secondary Outcomes (4)

• Survival time

  Time from registration to death due to any cause, assessed up to 5 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 5 years

• 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

  Up to 5 years

• Time to treatment failure

  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

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Treatment (temsirolimus)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (temsirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Sarcoma

Interventions

temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Scott Okuno

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: June 1, 2004
• Primary Completion: December 1, 2005
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)