Status:
TERMINATED
Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Lead Sponsor:
New Mexico Cancer Research Alliance
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Sarcoma
Eligibility:
All Genders
10+ years
Phase:
PHASE1
Brief Summary
Refractory soft tissue sarcoma remains a difficult malignancy to treat. The mammalian target of rapamycin (mTOR) is an enzyme that plays an important role in cancer cell survival. mTOR inhibitors, lik...
Detailed Description
Mammalian target of rapamycin (mTOR) inhibitors are anti-neoplastic agents with a wide potential range of clinical applications. The topoisomerase I inhibitor irinotecan is a potent DNA damaging drug....
Eligibility Criteria
Inclusion
- All patients, 10 years of age or older with biopsy proven advanced soft tissue sarcoma, who have failed at least one prior treatment for metastatic disease are eligible if there is measurable or evaluable disease per Response Evaluation Criteria In Solid Tumors (RECIST).
- Patients must have a life expectancy of at least 12 weeks.
- Prior surgery or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures.
- Patients must have a Zubrod performance status of 0-2.
- Patients (or their legal guardian) must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin \> 8 g/dl, platelet count ≥ 100 000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have a normal hepatic function with a total bilirubin \< the upper limit of normal and Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) \< 2 times the upper limit of normal, and adequate renal function as defined by a serum creatinine ≤ 1.5 upper limit of normal.
- Fasting total cholesterol level \< 350 mg/dL and triglyceride level \< 400 mg/dL is required.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months.
- Patients with brain metastases are eligible if they have been appropriately treated,are asymptomatic and no longer require corticosteroids.
Exclusion
- Pregnant women or nursing mothers are not eligible.
- Patients must not receive any other concurrent chemotherapy or radiation during this trial.
- Patients with severe medical illnesses such as uncontrolled diabetes, active infections, or uncontrolled psychiatric illnesses are not eligible.
- Patients with known hypersensitivity to temsirolimus or sirolimus, receiving concomitant antitumor therapy, or anticonvulsant therapy, or cardiac antiarrhythmic drugs are not eligible.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00996346
Start Date
October 1 2009
End Date
November 1 2013
Last Update
September 1 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106