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17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas - NCT00096005-32224(Clinical Trial 122486)



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City:  Jacksonville
State:  
FL
Zip Code: 32224
Conditions: Lymphoma - Unspecified Adult Solid Tumor, Protocol Specific
Purpose: RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop cancer cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of 17-AAG by making cancer cells more sensitive to the drug. Combining 17-AAG with bortezomib may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of giving 17-AAG together with bortezomib in treating patients with advanced solid tumorsor lymphomas. (Accrual for lymphoma patients closed as of 11/27/09)
Study summary: OBJECTIVES: - Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) and bortezomib in patients with advanced solid tumors or lymphomas (Accrual for Lymphoma Patients Closed as of 11/27/09). - Determine changes in biomarkers (e.g., HSP70, client proteins, and ubiquitination of proteins) in peripheral blood mononuclear cells and tumor specimens from patients with advanced solid tumors or lymphomas(Accrual for Lymphoma Patients Closed as of 11/27/09) treated with this regimen. - Determine responses in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG and bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 12 additional patients are treated as above* at the MTD. NOTE: *Bortezomib is not administered on day 1 of course 1 only. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor or lymphomas (Accrual for Lymphoma Patients Closed as of 11/27/09) - Refractory to standard treatment OR no standard treatment that is potentially curative or capable of prolonging life expectancy exists - Tumor amenable to biopsy (patients accrued at the MTD only) - No CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL Hepatic - Bilirubin ≤ 2 times upper limit of normal (ULN) - AST ≤ 2.5 times ULN - Alkaline phosphatase ≤ 2 times ULN (5 times ULN if due to liver involvement) Renal - Creatinine ≤ 2 times ULN Cardiovascular - QTc < 500 msec for men (470 msec for women) - LVEF > 40% by echocardiogram - Ejection fraction normal by echocardiogram (for patients who have received prior anthracycline therapy) - No cardiac symptoms ≥ grade 2 - No New York Heart Association class III or IV heart failure - No myocardial infarction within the past year - No active ischemic heart disease within the past year - No congenital long QT syndrome - No left bundle branch block - No history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs - No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine) - No poorly controlled angina - No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) - No other significant cardiac disease Pulmonary - Pulse oximetry at rest and exercise < 88% (per Medicare guidelines) - No pulmonary symptoms ≥ grade 2 - No significant pulmonary disease requiring oxygen supplementation or causing a severe limitation in activity - No symptomatic pulmonary disease requiring medication including any of the following: - Dyspnea on or off exertion - Paroxysmal nocturnal dyspnea - Oxygen requirement and significant pulmonary disease, including chronic obstructive/restrictive pulmonary disease - No home oxygen use that meets the Medicare criteria - No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine) Neurologic - No seizure disorder - No sensory peripheral neuropathy > grade 1 - No neuropathic pain of any etiology - Patients with residual peripheral neuropathy ≤ grade 1 due to oxaliplatin therapy allowed Other - No uncontrolled infection - No prior serious allergic reaction to eggs - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing to return to Mayo Clinic Rochester, Mayo Clinic Arizona, or Mayo Clinic Florida for follow up PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy or biologic therapy - No concurrent prophylactic colony-stimulating factors - No concurrent immunotherapy, biologic therapy, or gene therapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy Endocrine therapy - Concurrent steroids (at a stable dose for ≥ 4 weeks) for comorbid conditions (e.g., adrenal insufficiency or rheumatoid arthritis) allowed Radiotherapy - More than 4 weeks since prior radiotherapy - No prior radiotherapy that potentially included the heart in the field (e.g., mantle) or chest - No prior radiotherapy to > 25% of bone marrow - No prior radiopharmaceuticals - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - More than 8 weeks since prior UCN-01 - No concurrent warfarin - Low molecular weight heparin allowed - No concurrent medications that prolong or may prolong QTc interval - No other concurrent investigational therapy
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Data Source: ClinicalTrials.gov
Date Processed: April 8, 2010
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