Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Completed · Phase 2

Conditions studied: Myxofibrosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Leiomyosarcoma, Recurrent Liposarcoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Undifferentiated Pleomorphic Sarcoma, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7

In brief

This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT01653028

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2012-08-22

Last updated by the study team

2017-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed sarcoma that is metastatic and/or locally advanced or locally recurrent and unresectable; confirmation of pathologic diagnosis will be performed at the registering site; patients will been rolled on one of five cohorts of the study:
• Cohort 1: liposarcoma
• Cohort 2: leiomyosarcoma (non-uterine)
• Cohort 3: undifferentiated sarcoma (including malignant fibrous histiocytoma and myxofibrosarcoma)
• Cohort 4: malignant peripheral nerve sheath tumor
• Cohort 5: other sarcomas
• Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST) 1.1; note: defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
• Any number of prior therapies is permitted; note: the last dose of systemic therapy (including tyrosine kinase inhibitors) must have been given >= 4 weeks prior to initiation of study therapy; patients receiving BCNU or mitomycin C must have received their last dose of such therapy at least 6 weeks prior to initiation of therapy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelet count >= 100,000/mcL
• Total bilirubin =< 1.5 x institutional upper limit of normal
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (alanine aminotransferase [AST]) < 3 x institutional upper limit of normal if no liver metastases or < 5 x institutional upper limit of normal if liver metastases present
• Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73m\^2 for patients with creatinine levels above institutional normal
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MLN8237 administration
• Ability to understand and the willingness to sign a written informed consent document
• According to current guidelines, patients must be able to take oral medication and to maintain a fast as required for approximately one hour before and two hours after MLN8237 administration

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had radiation therapy to more than 25% of the bone marrow; whole pelvic radiation is considered to be over 25%
• Patients who are receiving any other investigational agents
• Patients with known brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237 including, but not limited to, established allergic reaction to benzodiazepines
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, New York Heart Association (NYHA) class II-IV heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women; note: women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration; breastfeeding should be discontinued if the mother is treated with MLN8237
• Leiomyosarcoma of the uterus
• Patients known to be human immunodeficiency virus (HIV)-positive on antiretroviral therapy
• Prior allogeneic bone marrow or organ transplantation
• Known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease, requirement for supplemental oxygen, or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237
• Requirement for constant administration of proton pump inhibitor, histamine-2 (H2) antagonist, or pancreatic enzymes; note: intermittent uses of antacids or H2 antagonists are allowed
• Inability to swallow oral medication or to maintain a required fast for approximately one hour before and two hours after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption or resection of pancreas or upper bowel
• Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study

Where it is running

• The Medical Center of Aurora — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Rocky Mountain Cancer Centers-Boulder — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers-Penrose — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Midtown — Denver, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Rocky Mountain Cancer Centers-Rose — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program NCORP — Denver, Colorado, United States
• Mercy Medical Center — Durango, Colorado, United States
• Comprehensive Cancer Care and Research Institute of Colorado LLC — Englewood, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Mountain Blue Cancer Care Center — Golden, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Rocky Mountain Cancer Centers-Greenwood Village — Greenwood Village, Colorado, United States
• Rocky Mountain Cancer Centers-Lakewood — Lakewood, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• Rocky Mountain Cancer Centers-Sky Ridge — Lone Tree, Colorado, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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