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

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT00996346
Phase
PHASE1
Status
Terminated

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan&Temsirolimus:Arm1, Level 1 — DRUG
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
  • Irinotecan&Temsirolimus:Arm 1, Level 2 — DRUG
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.
  • Irinotecan&Temsirolimus:Arm 2, Level 1 — DRUG
    Irinotecan is given first over 60 minutes followed by temsirolimus over 30 minutes. No intrapatient dose escalations are allowed. Treatment continues until disease progression or intolerable side effects develop.

Study Details

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.

Key Dates

Start date
Oct 31, 2009
Status verified
Aug 2015
Primary completion
Nov 30, 2011
Completion
Nov 30, 2013

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan&Temsirolimus:Arm 1, Level 1
    Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest. One cycle is four weeks.
  • Experimental: Irinotecan&Temsirolimus:Arm 1, Level 2
    Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest. One cycle is four weeks.
  • Experimental: Irinotecan&Temsirolimus:Arm 2, Level 1
    Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest. One cycle is four weeks.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Irinotecan [ Time Frame: Up to 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-

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By research site
University of New Mexico Cancer Center· Albuquerque, NM

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