A Phase 1, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612) in Advanced Malignancies

Background: * The dimethane sulfonates are a group of agents that were identified as active against renal cell carcinoma in the NCI anticancer drug screen. * In vitro studies showed that dimethane sulfonates have properties in common with alkylating agents, but are unlike conventional alkylators (such as nitrogen mustards, BCNU, or busulfan) in that they are active against renal cell carcinoma (RCC). Objective: Primary: -To determine dose-limiting toxicity (DLT), MTD and recommended phase II dose (RPTD) of dimethane sulfonate (DMS612, NSC 281612) when administered by intravenous (IV) bolus on day 1 and 2 of a 21-day cycle. Eligibility: * Patients must have histologically confirmed solid tumor malignancy or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Any prior chemotherapy therapy is allowed in this protocol. No more than 2 prior cytotoxic chemotherapy regimens are allowed. * Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of Dimethane sulfonate in patients less than 18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials. * ECOG performance status 0-2 (Karnofsky greater than or equal to 60%,). * Life expectancy of 3 months or greater. * Patients must have acceptable organ and marrow function as defined below: leukocytes greater than or equal to 3,000/mcL, absolute neutrophil count greater than or equal to 1,500/mm(3), platelets greater than or equal to 100,000/, mm(3) total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT), less than or equal to 2.5 times the institutional upper limit of normal, creatinine within normal institutional limits or creatinine clearance greater than 50mL/min for patients with creatinine levels above institutional normal. Design: This is a Phase I study of the safety, pharmacokinetics, pharmacodynamics and antitumor activity of IV DMS612, NSC 281612, designed as an open-label, dose-escalation study to determine the RPTD of DMS612, NSC 281612 based on safety and pharmacokinetics. With the 02/09/2015 amendment and change in schedule to evaluate a day 1 and 2 dosing every 6 weeks the following schema will be used: Dose Level Dose of NSC 281612 Escalation (%) * 1 3.5 mg/m2 on Day 1 and 2 -33 4A 4.5 mg/m2 on Day 1 and 2 --- 5A 6 mg/m2 on Day 1 and 2 33 6A 8 mg/m2 on Day 1 and 2 67 7A 10.5 mg/m2 on Day 1 and 2 33 7B 10.5 mg/m2 on Day 1 and 2 q 6 weeks --- 8A 14 mg/m2 on Day 1 and 2 33 8B 14 mg/m2 on Day 1 and 2 q 6 weeks --