Status:
COMPLETED
Cixutumumab and Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of cixutumumab and temsirolimus in treating patients with locally advanced or metastatic cancer. Monoclonal antibodies, such as cixutumumab, c...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability; and to determine maximum tolerated dose (MTD) of the combination of IMC-A12 (cixutumumab) with temsirolimus in patients with or without...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic cancer
- Patients enrolled in the expansion cohorts may be on antidiabetic treatment, but baseline glucose should be =\< 120
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study; patients must also have signed an authorization for the release of their protected health information
- Patients are allowed to have unlimited prior treatments
- Patients must be registered in the MD Anderson Cancer Center (MDACC) institutional database (CORE) prior to treatment with study drug
- Estimated life expectancy of greater than 3 months
- Patients must be ≥ 4 weeks beyond treatment of any chemotherapy, other investigational therapy, biological, targeted agents or radiotherapy, and must have recovered to =\< grade 1 toxicity or previous baseline for each toxicity; exceptions: patients must be \>= 6 weeks beyond treatment with monoclonal antibodies; patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae, or skull were not included in the radiotherapy field
- Patients must be \>= 2 weeks beyond treatment of hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
- Absolute neutrophil count \>= 1500/mL
- Platelets \>= 100,000/mL
- Creatinine =\< 2 X upper limit of normal (ULN)
- Total (T.) bilirubin =\< 1.5 X ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and/or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 X ULN
- Women of childbearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 3 months after the last dose
- Patients must be \>= 16 years of age; patients with Ewing's Sarcoma must be \>= 14 years of age
Exclusion
- Patients may not be receiving any other investigational agents
- Patients who are pregnant or breastfeeding
- Patients with history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days
- Patients with uncontrolled intercurrent illness including, but not limited to, active infection requiring hospitalization
- Patients with history of hypersensitivity to monoclonal antibody treatment or immunosuppressant agents
- Patients with history of cerebrovascular accident (CVA), myocardial infarction or unstable angina within the previous six months before starting therapy
- Patients with New York Heart Association class III or greater congestive heart failure or uncontrolled hyperlipidemia (cholesterol \> 300 mg/dl; triglyceride 2.5 X ULN despite lipid lowering agent)
- Patients with fasting blood sugar \> 120; patients who are on oral hypoglycemic agents and insulin will be excluded; exception: patients in the expansion cohorts may be on antidiabetic treatment (including hypoglycemic agents and/or insulin) if controlled
- Patients on drugs that are strong P450 cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers; these drugs should be stopped 5 half-lives prior to starting investigational agents with temsirolimus; the strong inducing or inhibiting agents should not restart until 1 week after the end of study treatment; the principal investigator (PI) or his designee will go over/check the list of medication for individual patients; NOTE: Physiologic replacement of steroids (with either prednisone or hydrocortisone) in patients with adrenalectomy will be allowed
- Patients with history of brain metastasis are eligible, however the brain metastases should have been treated (treatment defined as surgery or radiation therapy \[RT\]) and the patient should have been free from symptoms/signs and off steroids for at least 3 months before study entry
- Patients with highly aggressive lymphoma (i.e. Burkitt's)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00678769
Start Date
May 1 2008
End Date
October 1 2015
Last Update
November 4 2015
Active Locations (2)
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1
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030