ALT-803 in Treating Patients with Advanced Cancer

Inclusion Criteria

• Patients must have histologically or cytological confirmed malignancy in the following disease groups: melanoma that is metastatic or unresectable, non-small cell lung carcinoma, renal cell carcinoma, sarcoma, colon carcinoma, non-Hodgkin lymphoma, squamous cell head and neck carcinoma, or cutaneous squamous cell carcinoma, for which standard curative or palliative measures do not exist or are no longer effective; the primary site may be cutaneous or unknown, but mucosal and ocular primaries are excluded * Note: patients with non-small lung cancer must have had prior epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) testing; patients with sensitizing mutations in EGFR or ALK rearrangements should have been treated with prior targeted agents and have had progression or discontinued due to toxicity from these agents
• For cohort 3 only, patients must be able to safely undergo pre and post-treatment biopsy, i.e., at least one readily accessible lesion or palpable lymph node metastasis arising from any solid tumor cancer or lymphoma * NOTE: this may include cutaneous and subcutaneous tumors using injection by palpation or ultrasound guidance * NOTE: the target lesion must be >= 1.5 cm on its longest diameter, be at least 5 mm thick, and have distinct borders * NOTE: deep seated lesion(s) that are deemed hazardous to inject or lesion(s) close to vital structures that might be impinged with tumor swelling are excluded as targeted tumor * NOTE: cohort 3 should be selected for patients with injectable cutaneous lesion(s), unless the patient elects not to receive IT injection and/or undergo pre and post-treatment biopsies
• Prior therapy requirements: * At least one prior therapy using an agent with the potential for prolonged remission (generally includes interleukin-2, checkpoint-blocking antibodies, or adoptive cell therapy) * At least 4 weeks from last dose of prior chemotherapy or immunomodulator therapy with resolution of the acute toxicities; for patients coming off molecularly-targeted therapy, at least 2 weeks since last dose and recovery from laboratory and constitutional toxicities; patients must meet entry eligibility criteria * At least 2 weeks from completion of prior radiation therapy with no residual radiation toxicities * At least 4 weeks from last dose of prior investigational therapy with recovery to meet baseline eligibility criteria * Not receiving any current anticancer therapy * Note: any patient whose tumors carry a B-Raf proto-oncogene, serine/threonine kinase (BRAF) v600 mutation should either be excluded, or may be included after experiencing progression following treatment with BRAF inhibitor regimen or if they consent and agree to forgo Food and Drug Administration (FDA)-approved therapies that increase median survival
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
• Both men and women of all races and ethnic groups are eligible for this trial
• Life expectancy of greater than 6 months
• Leukocytes >= 3,000/mcL
• Absolute lymphocytes count >= 500/mcL
• Absolute neutrophil count >= 1,000/mcL (without hematopoietic growth factors)
• Platelets >= 100,000/mcL (without transfusion)
• Hemoglobin >= 10 g/dL (may be transfused but must be stable without clinical evidence of ongoing blood loss or hemolysis)
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Creatinine within normal institutional limits OR
• Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• No history of severe chronic obstructive pulmonary disease (COPD) or emphysema or interstitial lung disease currently on home supplemental oxygen; patients with NSCLC with stable COPD or emphysema not requiring supplemental oxygen are eligible
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before 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 before the study, for the duration of study participation, and 4 months after the completion of ALT-803 administration
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who have had chemotherapy, targeted therapy, or radiotherapy, and have not recovered from acute toxicity to their pretreatment baseline or to a grade 1 level within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Note: patients with chronic residual prior therapy-related toxicity (e.g. vitiligo, alopecia, low grade neuropathy), or in the consensus opinion of the Cancer Immunotherapy Trials Network (CITN)/Cancer Therapy Evaluation Program (CTEP) investigators would not impact the safety of the patient or the integrity of the study, are not excluded * Note: for resolution of autoimmune toxicity from prior immune therapy, patients must be off steroids for at least 30 days without relapse of autoimmune toxicity, or it must be at least 30 days from their last dose of infliximab or related immunosuppressive therapy without relapse of autoimmune toxicity
• Patients who are receiving any other investigational agents
• Patients with known brain metastases should be excluded from this clinical trial; previously treated brain metastases, neurologically stable, and no ongoing or anticipated need for steroid therapy are eligible
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant lung disease or psychiatric illness/social situations that would limit compliance with study requirements; patient who, in the clinical judgment of the investigator, have underlying risk factors for cardiac disease should be excluded or undergo clearance stress-based cardiac function testing; the pre-treatment corrected QT interval (QTc) must be < 500 msec
• Patients with thyroid disease should be excluded unless euthyroid on suppressive or replacement therapy
• Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ALT-803
• Human immunodeficiency virus (HIV)-positive patients
• Positive hepatitis C serology or active hepatitis B infection
• Active bacterial or fungal infection; all prior infections must be resolved following optimal therapy
• Chronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapy
• Immunosuppressive therapy within 30 days prior to initiation of protocol therapy
• Inability to home monitor blood pressure
• Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria or serious arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmias requiring chronic therapy)