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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00923520 |
Purpose
Background:
Objectives:
Eligibility:
Design:
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma Breast Cancer Colon Cancer Lung Cancer Non-Hodgkin Lymphoma |
Drug: dimethane sulfonate (DMS612, NSC 281612) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612, NSC 281612) in Advanced Malignancies |
| Estimated Enrollment: | 39 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Background:
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 days 1, 8 and 15 of a 28-day cycle.
Secondary:
Eligibility:
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. A 1.5 mg/m(2) dose level will be the starting dose level of DMS612, NSC 281612.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients must have acceptable organ and marrow function as defined below:
EXCLUSION CRITERIA:
Contacts and Locations| Contact: NCI Referral Office | 1-888-NCI-1937 | ncicssc@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
More Information
| Responsible Party: | National Institutes of Health ( CTEP/National Cancer Institute ) |
| Study ID Numbers: | 090111, 09-C-0111 |
| Study First Received: | June 17, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00923520 History of Changes |
| Health Authority: | United States: Federal Government |
|
Solid Tumors Phase I Lymphoma Dimethane Sulfonate (DMS612, NSC 281612) Cancer Solid Tumor Renal Cell Cancer |
Kidney Cancer Breast Cancer Colon Cancer Lung Disease Non-Hodgkin Lymphoma NHL |
|
Thoracic Neoplasms Gastrointestinal Diseases Colonic Diseases Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Respiratory Tract Diseases Urologic Diseases Lung Neoplasms Kidney Neoplasms Kidney Diseases Lymphoma Breast Diseases Respiratory Tract Neoplasms Immunoproliferative Disorders |
Neoplasms by Histologic Type Digestive System Neoplasms Immune System Diseases Skin Diseases Breast Neoplasms Intestinal Diseases Intestinal Neoplasms Carcinoma Lymphatic Diseases Neoplasms Digestive System Diseases Lung Diseases Carcinoma, Renal Cell Gastrointestinal Neoplasms Lymphoproliferative Disorders |