A Phase 1, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612) in Advanced Malignancies
|ClinicalTrials.gov Identifier: NCT00923520|
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : February 14, 2018
- 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.
- 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.
- Patients 18 years of age and older who have been diagnosed with cancer that has not responded well to standard treatments.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Breast Cancer Colon Cancer Lung Cancer Non-Hodgkin Lymphoma||Drug: dimethane sulfonate (DMS612, NSC 281612)||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612, NSC 281612) in Advanced Malignancies|
|Study Start Date :||March 25, 2009|
|Primary Completion Date :||May 12, 2016|
|Study Completion Date :||May 12, 2016|
DMS 612 on day 1 and 2 with doses starting at 3.5mg/m2 to 18.5mg/m2 every 21 days until MTD is reached
Drug: dimethane sulfonate (DMS612, NSC 281612)
DMS 612 on day 1 and 2 with doses starting at 3.5mg/m2 to 18.5mg/m2 until MTD is reached
- Determine the Maximum Tolerated Dose [ Time Frame: End of Cycle 1 ]
- Evaluate non-dose limiting toxicity [ Time Frame: Treatment Completion ]
- PK [ Time Frame: Collection of Samples ]
- Anti-tumor Effects [ Time Frame: Disease Progression ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923520
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Anish Thomas, M.D.||National Cancer Institute (NCI)|