Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas
Adult Grade III Lymphomatoid Granulomatosis, AIDS-related Peripheral/Systemic Lymphoma, Anaplastic Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Adult Grade III Lymphomatoid Granulomatosis
Eligibility Criteria
Inclusion Criteria: 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 Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL 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) Creatinine ≤ 2 times ULN 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 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) 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 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 More than 4 weeks since prior immunotherapy or biologic therapy No concurrent prophylactic colony-stimulating factors No concurrent immunotherapy, biologic therapy, or gene therapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy Concurrent steroids (at a stable dose for ≥ 4 weeks) for comorbid conditions (e.g., adrenal insufficiency or rheumatoid arthritis) allowed 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 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy and enzyme inhibitor therapy)
Patients receive tanespimycin 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 tanespimycin and bortezomib until the 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.