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A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors Clinical research trials and A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors. A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors  A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors
A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors
For Condition: Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 17-(Allylamino)-17-demethoxygeldanamycin (AAG) is a benzoquinoid ansamycin with tumor growth inhibitory properties. Its presumed mechanism of action is its ability to interfere with the chaperone function of heat shock protein 90 (Hsp90). This phase I study will determine the maximally-tolerated dose (MTD) and toxicity profile of AAG administered as a one hour intravenous infusion on days 1, 4, 15 and 18 of each 4 week cycle in adult patients with solid tumors. It will also determine the molecular effects of AAG on the protein levels of Hsp72, Lck and Raf-1 in peripheral lymphocytes in patients. Whenever possible, tumor biopsies for molecular marker measurements will also be obtained. Plasma and urine pharmacokinetics will also be monitored.
Details: 17-(Allylamino)-17-demethoxygeldanamycin (AAG) is a benzoquinoid ansamycin with tumor growth inhibitory properties. Its presumed mechanism of action is its ability to interfere with the chaperone function of heat shock protein 90 (Hsp90). This phase I study will determine the maximally-tolerated dose (MTD) and toxicity profile of AAG administered as a one hour intravenous infusion on days 1, 4, 15 and 18 of each 4 week cycle in adult patients with solid tumors. It will also determine the molecular effects of AAG on the protein levels of Hsp72, Lck and Raf-1 in peripheral lymphocytes in patients. Whenever possible, tumor biopsies for molecular marker measurements will also be obtained. Plasma and urine pharmacokinetics will also be monitored.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA 18 years old or greater. ECOG performance status of 0-2. Patients must have advanced solid tumors (no leukemia but non-Hodgkin's lymphoma is allowed) for which no effective therapeutic regimen exists which can prolong patient survival. Able to understand and give informed consent. Life expectancy greater than or equal to 3 months. Absolute neutrophil count (ANC) greater than or equal to 2,000/microliter and platelets greater than or equal to 100,000/ microliter. Serum creatinine and total bilirubin within institution limits of normal, and AST less than or equal to twice the upper limit of normal (at National Naval Medical Center this is a serum creatinine clearance less than or equal to 1.5 mg/dL OR a creatinine clearance on a 24 hour urine collection of greater than or equal to 60 mL/min, an AST less than or equal to 98 U/L and a total bilirubin less than or equal to 1.3 mg/dL). Prior chemotherapy is allowed, but patients must be off any chemotherapy or radiation therapy for at least 4 weeks prior to starting this study and must have recovered from acute effects of prior therapies. Willingness to consent to research bone marrow aspiration and pharmacokinetic sampling studies. EXCLUSION CRITERIA Active central nervous system involvement with tumor. Patients with human immunodeficiency virus positivity due to the potential for decreased tolerance and may be at increased risk for severe side effects. Pregnant or breast feeding women. Medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained. Concomitant treatment with drugs that interfere with hepatic CYP3A4 metabolism that cannot be stopped prior to starting on this study. Specifically, this will be defined for this study as any of the following: grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporin, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, and the HIV protease inhibitors, indinavir and nelfinavir. Serious hypersensitivity reaction to egg products.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990054; 99-C-0054
Study Start Date: February 25, 1999
Record last reviewed: January 28, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001804
Other Neoplasm Studies:
1. Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected Malignant Disease
2. A Phase I Trial of Continuous Infusion UCN-01 in Patients with Refractory Neoplasms
3. Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
4. Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
5. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
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A Phase I and Pharmacologic Study of 17-(Allylamino)-17-demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients with Solid Tumors
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