Overview

Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas

Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
All
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, like temsirolimus, have shown activity in sarcoma. Irinotecan is a chemotherapy drug that has also been used to treat sarcoma. However, it is unknown whether combining these two drugs would result in improved efficacy with acceptable toxicity. Therefore, the goal of this phase I study is to determine the maximum tolerated dose (MTD) and toxicity profile of combination temsirolimus and irinotecan both administered intravenously on a weekly basis to refractory soft tissue sarcoma patients.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New Mexico Cancer Care Alliance
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Camptothecin
Complement Factor H
Everolimus
Irinotecan
Sirolimus
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.