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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical research trials and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery clinical trial. Human subjects frequently get the finest healthcare available for their 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "1" Clinical Trials Conditions > 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery  17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
For Condition: adult solid tumor,angiocentric immunoproliferative lesions,Non-Hodgkin's Lymphoma,Hodgkin's lymphoma,adult T-cell leukemia and lymphoma,Cutaneous T-Cell Lymphoma
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have solid tumors that cannot be removed by surgery.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), administered at 2 different dosing schedules, in patients with unresectable solid tumors. - Determine the pharmacokinetics of this drug in these patients. - Assess the effect of this drug on heat shock protein chaperone complex components and client proteins in lymphoma tissue obtained pre- and post-treatment in patients with relapsed lymphoma. - Determine any response to this drug in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups. - Group I: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. - Group II: Patients receive 17-AAG IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 solid tumor patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 lymphoma patients are accrued and treated as in group II at the MTD. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 58-130 patients (30-72 for group I and 28-58 for group II) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically or cytologically confirmed solid tumor - Unresectable disease - Hodgkin's or non-Hodgkin's lymphoma - Relapsed disease - Failed at least 1 prior therapy - Neoplastic cells are accessible through biopsy - No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists - No CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver involvement) Renal: - Creatinine no greater than 1.25 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception - No uncontrolled infection - No seizure disorder - No history of serious allergic reaction to eggs PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 4 weeks since prior immunotherapy - More than 4 weeks since prior biologic therapy - No concurrent immunotherapy - No concurrent routine or prophylactic use of a colony-stimulating factor (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered from acute and reversible toxic effects - No other concurrent chemotherapy Endocrine therapy: - No concurrent birth control pills - No concurrent steroids as anti-emetics Radiotherapy: - More than 4 weeks since prior radiotherapy - No prior radiotherapy to more than 25% of the bone marrow - No prior radiopharmaceuticals - No concurrent radiotherapy Surgery: - Not specified Other: - No concurrent 3A4 enzyme inhibitors (e.g., verapamil, erythromycin, miconazole, or ketoconazole) - No concurrent investigational ancillary therapy - No concurrent enrollment in another study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy approaches, or gene therapy) for symptom control or therapeutic intent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesErlichman, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Charles Erlichman 507-284-4918
Additional Information:
Study ID Numbers: CDR0000067283; MAYO-990102,NCI-T99-0058
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004075
Other Adult T-Cell Leukemia And Lymphoma Studies:
1. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
2. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
3. Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma
4. A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
5. Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma
Related Studies:
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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
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