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A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) Clinical research trials and A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX). A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)  A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)
A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)
For Condition: Astrocytoma,Glioma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 2-Chlorodeoxyadenosine (2CDA) is an adenosine analog which resists deamination. The resulting derangement of nucleotide metabolism causes cell death. It is an active agent against recurrent malignant glioma and it has been shown to inhibit DNA repair following ionizing radiation. This phase I study will determine the maximum tolerated dose of 2CDA given by weekly continuous infusion during a course of limited field cranial radiation in patients with anaplastic astrocytomas.
Details: 2-Chlorodeoxyadenosine (2CDA) is an adenosine analog which resists deamination. The resulting derangement of nucleotide metabolism causes cell death. It is an active agent against recurrent malignant glioma and it has been shown to inhibit DNA repair following ionizing radiation. This phase I study will determine the maximum tolerated dose of 2CDA given by weekly continuous infusion during a course of limited field cranial radiation in patients with anaplastic astrocytomas.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with histologically proven Dumas Duport grade III astrocytoma or anaplastic astrocytoma confined to one or both hemispheres of the brain; or glioblastoma multiforme not eligible for the HMX protocol. Patients must not have received prior radiotherapy or chemotherapy. Patients having prior biopsy, subtotal or near-total resections are eligible. Patients must have adequate hematologic (WBC greater than or equal to 3.0, AGC greater than or equal to 900, HGB greater than or equal to 10.0, ALC greater than or equal to 900, PLT greater than or equal to 100,000); Renal (estimated CrCl greater than or equal to 95 ml/min., or serum Cr less than or equal to 1.3); and Hepatic (LFT's less than or equal to 2.5 times the upper limit of normal) function. Patients must be older than 18 years. Patients must have had surgery and/or biopsy not greater than 3 months prior to initial evaluation. Radiologic evaluation (i.e. magnetic resonance imaging (MRI) and/or computed tomography (CT)) must be obtained not greater than 3 weeks prior to initial evaluation. Histologic diagnosis of high grade astrocytoma must be confirmed by NIH neuropathology after mandatory review of slides from biopsy or resected specimens. Patients must sign an informed consent and Durable Power of Attorney statement after an in-depth discussion of risks, benefits and treatment alternatives. Patients should have a life expectancy of greater than 6 months. Patients should have a performance status of greater or equal to 60 (Karnofsky) or less than or equal to 2 (ECOG). Lumbar puncture (LP) for CSF drug levels is optional, but will be strongly encouraged. However, patients unable to safely undergo LP or unwilling to have LP will be eligible.
Total Enrollment: 42
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950092; 95-C-0092
Study Start Date: March 20, 1995
Record last reviewed: January 15, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001433
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1. A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)
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4. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
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A Phase I Study of 2-Chlorodeoxyadenosine and Radiation for the Treatment of High Grade Glioma (CDX)
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