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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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
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 and 2 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.
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 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: National Cancer Institute Referral Office For more information at the NIH Clinical Center contact | |
| United States, Pennsylvania | |
| Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
More Information
| Responsible Party: | Susan E. Bates, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00923520 History of Changes |
| Obsolete Identifiers: | NCT00888121 |
| Other Study ID Numbers: | 090111, 09-C-0111 |
| Study First Received: | June 17, 2009 |
| Last Updated: | December 29, 2011 |
| 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 |
|
Breast Neoplasms Carcinoma Colonic Neoplasms Carcinoma, Renal Cell Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Colorectal Neoplasms Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |