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

NCT00923520 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-12-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

DMS 612

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Anish Thomas, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-25
Primary Completion
2016-05-12
Completion
2018-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923520 on ClinicalTrials.gov