NCT00923520

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

Completed Phase 1 Last updated 5 December 2018

What this trial tests

Phase 1 trial testing DMS 612 in Renal Cell Carcinoma in 60 participants. Completed in 3 December 2018.

Timeline

25 March 2009

Primary endpoint
12 May 2016

3 December 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	25 March 2009
Primary completion	12 May 2016
Estimated completion	3 December 2018
Sites	3 locations across United States

Drugs / interventions tested

• DMS 612 — full drug profile →

Conditions studied

• Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →
• Breast Cancer — all drugs for Breast Cancer →
• Colon Cancer — all drugs for Colon Cancer →
• Lung Cancer — all drugs for Lung Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Renal Cell Carcinoma or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of the aldehyde dehydrogenase inhibitor disulfiram on the plasma pharmacokinetics, metabolism, and toxicity of benzaldehyde dimethane sulfonate (NSC281612, DMS612, BEN) in mice.
   Parise RA, Beumer JH, Clausen DM, Rigatti LH, et al · · 2013 · cited 5× · PMID 24061865 · DOI 10.1007/s00280-013-2296-5
2. A phase i study of DMS612, a novel bifunctional alkylating agent.
   Appleman LJ, Balasubramaniam S, Parise RA, Bryla C, et al · · 2015 · cited 4× · PMID 25467180 · DOI 10.1158/1078-0432.ccr-14-1333
3. Characterization of the metabolism of benzaldehyde dimethane sulfonate (NSC 281612, DMS612).
   Parise RA, Eiseman JL, Clausen DM, Kicielinski KP, et al · · 2015 · cited 3× · PMID 26193988 · DOI 10.1007/s00280-015-2828-2