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

Completed · Phase 1

Conditions studied: Renal Cell Carcinoma, Breast Cancer, Colon Cancer, Lung Cancer, Non-Hodgkin Lymphoma

In brief

Background: * Dimethane sulfonate (DMS612) is an investigational drug that is being administered to humans for the first time in people with advanced tumors. More information on the maximum tolerated dose of DMS612 will help researchers identify whether the drug is suitable for use in treating certain kinds of cancer, particularly renal cell carcinoma. Objectives: * To determine the maximum tolerated dose of DMS612 (the highest dose that does not cause unacceptable side effects) and evaluate any side effects. * To see if DMS612 has any effect on patients tumors through blood tests and laboratory studies. * To learn how the body processes DMS612. Eligibility: * Patients 18 years of age and older who have been diagnosed with cancer that has not responded well to standard treatments. Design: * Pre-treatment evaluation visit to determine eligibility: * Physical examination * Blood and urine tests * Chest X-ray; electrocardiogram; CAT scan of chest, abdomen, pelvis, and other areas of the body if needed * Other possible tests, such as magnetic resonance imaging (MRI) or positron emission tomography (PET) * Patients will receive one dose of DMS612 by intravenous infusion once a week for 3 weeks, followed by 1 week without the drug. Doses will be adjusted based on possible side effects and cancer response. The disease will be evaluated after three cycles of the drug. * Evaluations during the treatment period: * Physical examination and reviews of side effects. * Blood draws to evaluate the effectiveness of the drug, and how it is processed by the body. * CAT scan at the end of every two cycles (every 8 weeks). * Other scans and imaging procedures as required by the study doctors.

Key facts

Study ID: NCT00923520
Run by: National Cancer Institute (NCI)
People needed: 60
Starts: 2009-03-25
Expected to finish: 2018-12-03
Last updated by the study team: 2018-12-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients who have not recovered (CTC less than or equal to grade I) from adverse events due to prior treatments
Patients may not have received more than 2 prior cytotoxic regimens.
Patients may not be receiving any other investigational agent with therapeutic anticancer intent.
Patients with history of CNS metastasis, unless control has been achieved with either radiation or surgical resection at least 3 months prior to enrollment on study.
Patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (greater than 25% of bone marrow irradiated).
Uncontrolled medical illness including, but not limited to, ongoing or active infection, chronic or acute hepatitis, renal failure, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because DMS612 is likely to have toxicities similar to the alklyating agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DMS612, breastfeeding should be discontinued if the mother is treated with DMS612.
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with DMS612. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Patients are not eligible for the study if taking cytochrome P450-inducing anticonvulsants. This applies to patients with brain metastasis or those taking anticonvulsant for another reason (ie. Epilepsy).
Patients diagnosed with alcoholism may not be treated with disulfiram.
Patients may not be receiving agents thought to inhibit or induce the cytochrome p450 isoenzyme CYP3A4.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Hershey Medical Center — Hershey, Pennsylvania, United States
University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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