Statement: 3/4 participants in the primary trial suffered from Dose-limiting toxicities.
Primary_evidence: Outcome Measurement:    Recommended Dose Level for Phase II Testing (RPTD) (Phase I)   The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.   Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:   Any grade 4 hematologic toxicity   Hyperglycemia that cannot be stably controlled with diabetic medication   Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)   Time frame: During first course Results 1:    Arm/Group Title: Dose Level 1   Arm/Group Description: 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22   3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 3   Measure Type: Number   Unit of Measure: DLTs  2 Results 2:    Arm/Group Title: Dose Level -1   Arm/Group Description: 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22   3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22   Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 1   Measure Type: Number   Unit of Measure: DLTs  1