Cixutumumab and Temsirolimus in Treating Patients With Locally Advanced or Metastatic Cancer

Completed · Phase 1

Conditions studied: Malignant Neoplasm

In brief

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, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more cancer cells.

Key facts

Study ID

NCT00678769

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2008-05-01

Expected to finish

2015-10-01

Last updated by the study team

2015-11-04

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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