Atorvastatin in Treating Patients with p53-Mutant and Wild-Type Malignant Solid Tumors or Recurrent Hematologic Malignancies

Inclusion Criteria

• Ability of participant to understand this study, and participant to sign a written informed consent. Legally authorized representative is not allowed to sign consent for participant
• Participants with TP53 immunohistochemistry (IHC)-positive tumors
• Participants whose screening IHC shows TP53-IHC-negative including wild type (WT) and null. Number of participants enrolled with TP53-IHC-negative to be capped at 10
• Participants with histologic or cytologic confirmation of any malignant disease who are planning and eligible to undergo surgical resection. NOTE: For participants with solid tumors only
• Participants with previously treated AML, myelodysplastic syndrome (MDS), and hematologic malignancies are eligible if they relapse and have no concurrent or recent use (within the longer timeframe between < 5 half-lives or 14 days) for any investigational agent of systemic therapy including chemotherapy, immunotherapy, hormonal therapy, cancer vaccine, or local therapy for their cancer. Use of hydroxyurea is permitted while on study. NOTE: For participants with AML, MDS, and hematologic malignancies
• No concurrent or recent (within 30 days) use of systemic therapy including chemotherapy, immunotherapy, hormonal therapy, cancer vaccine, or local therapy for the cancer. NOTE: For participants with solid tumors only
• Formalin-fixed paraffin-embedded (FFPE) tumor tissue deemed adequate for IHC analysis and next generation sequencing (NGS) are required. Bone marrow aspirate samples from participants with AML, MDS, or any relapsed hematologic malignancies with known p53 mutation are required
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for solid tumor, and =< 2 for AML, MDS, or any relapsed hematologic malignancies with known p53 mutation participants
• Total bilirubin =<1.5 times upper limit of normal (ULN) (participants with Gilbert syndrome are eligible independent of bilirubin levels)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times ULN
• Serum creatinine =< 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min
• Serum albumin >= 2.5 g/dL
• A negative urine or serum pregnancy test within 7 days before day 1 dose of study medication, if female participant is of childbearing potential
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she should inform her treating physician immediately * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Men of child-bearing potential must not donate sperm while on this study and for 90 days after their last study treatment * NOTE: Acceptable forms of birth control are listed below: ** Sexual Abstinence OR *** One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) PLUS ** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)

Exclusion Criteria

• AFTER enrollment cap of 10: Participants whose screening IHC shows TP53-IHC-negative including wild type [WT] and null
• Current or anticipated use of other investigational agents while participating in this study
• Psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breast feeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants (if applicable)
• Diagnosis of squamous cell cancer of the oropharynx
• Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast), unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
• Prior use of statins is allowed if the daily dose is less than or equal to 40mg. Participants taking a daily statin dose greater than 40mg will be excluded
• History of rhabdomyolysis
• Active liver disease, as determined by elevation of AST/ALT/total bilirubin (see inclusion criteria) or requirement of treatment (e.g., anti-viral therapy for hepatitis B/C)
• Participants who currently consume substantial quantities of alcohol (male > 4 drinks a day, female > 2 drinks a day)
• Current use of cyclosporine, fibrates, or strong CYP3A4 inhibitors/inducers. Concurrent use of other drugs associated with myopathy. The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives lipid-modifying doses of niacin, cyclosporine, colchicine, or strong CYP 3A4 inhibitors
• Hypersensitivity to atorvastatin or any component of the formulation
• Untreated hypothyroidism
• Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of atorvastatin, or that may affect the interpretation of the results, or that may render the participant at high risk for treatment complications
• Inability to comply with study and follow-up procedures as judged by the investigator