Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Medicine and Dentistry New Jersey |
---|---|
Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00633087 |
Subjects will be asked to participate in this clinical trial to examine the safety of 2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors and hormone refractory prostate cancer. This agent works by blocking the metabolism of glucose in the cells of the body. Although all cells require glucose for metabolism, it is believed that cancer cells require significantly more glucose than normal cells to grow.
Therefore, even slight effects of glucose metabolism in cancer cells might result in the shrinkage of certain cancers. This agent has been given to humans before and has only caused mild nausea, vomiting and glucopenia (low blood sugar) at the doses given in these studies. This study will further examine the safety of 2-deoxyglucose in the treatment of advanced solid tumors and hormone refractory prostate cancer. The information obtained in this study will be used to design future clinical studies with 2-deoxyglucose. Subjects will be asked to take an oral solution of 2-deoxyglucose daily, by mouth, while on this study. They will be asked to have CT Scans, Bone Scans, and optional PET (Positron Emission Tomography) Scans prior to starting this study.
PET scans will also be performed shortly after the start of the study and after 2 cycles (6 weeks) of therapy.
Subjects will be asked to have a comprehensive physical examination and blood work prior to the start of the study. During the first 2 cycles of the study subjects will be asked to have blood drawn at different time intervals for the first 2 days of each cycle. While on the study, they will be asked to return to the clinic at intervals of 1 week for a physical examination and blood tests. Subjects will also be asked to have CT Scans and Bone Scans at intervals of 9 weeks while on the study.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: 2-deoxyglucose |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All previous clinically significant treatment-related toxicities have resolved to less than or equal to Grade
Exclusion Criteria:
For this reason and because Agent Class as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Phase I only: Inability to discontinue prohibited medications for 24 hours before and after dosing on Cycle
1, Day 1 of Weeks 1 and 2.
Contact: Chandrika Jeyamohan, RN, BSN | 732-235-8092 | jeyamocc@umdnj.edu |
Contact: Dorinda Metzger, RN, MSN | 732-235-6363 | metzgedo@umdnj.edu |
United States, New Jersey | |
The Cancer Institute of New Jersey | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Robert DiPaola, MD 732-235-7414 dipaolrs@umdnj.edu |
Study Chair: | Joseph Aisner, MD | UMDNJ/The Cancer Institute of New Jersey |
Responsible Party: | UMDNJ/The Cancer Institute of New Jersey ( Robert DiPaola ) |
Study ID Numbers: | 080402 |
Study First Received: | March 3, 2008 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00633087 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Infective Agents Prostatic Diseases Genital Neoplasms, Male Deoxyglucose |
Urogenital Neoplasms Genital Diseases, Male Antiviral Agents Hormones Prostatic Neoplasms |
Antimetabolites Anti-Infective Agents Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Genital Diseases, Male |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Deoxyglucose Prostatic Neoplasms |