Status:
TERMINATED
17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin and bortezomib in treating patients with relapsed or refractory hematologic cancer. Drugs used...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of PS-341 (Velcade, Bortezomib) in combination with 17-allyamino-17-demethoxygeldanamycin (17-AAG) in patients with relapsed or re...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia or acute lymphoblastic leukemia
- Not a candidate for potentially curative therapy
- WBC ≤ 10,000/mm\^3 OR WBC ≤ 40,000/mm\^3 that is stable for 5 days (hydroxyurea allowed)
- No acute promyelocytic leukemia
- Non-Hodgkin's lymphoma (NHL), including 1 of the following subtypes:
- Small lymphocytic lymphoma
- Marginal zone lymphoma
- Lymphoplasmacytic lymphoma
- Follicular lymphoma
- Mantle cell lymphoma
- Diffuse large B-cell lymphoma
- Anaplastic large cell lymphoma
- Peripheral T-cell lymphoma
- Extranodal NK/T cell lymphoma (nasal and nasal type)
- Enteropathy-type T-cell lymphoma
- Hepatosplenic T-cell lymphoma
- Angioimmunoblastic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Chronic lymphocytic leukemia (CLL)
- Patients with NHL or CLL must meet the following criteria:
- Ineligible for, or refused potentially curative stem cell transplantation
- Transformed lymphoma/Richter's transformation, defined as the transformation of low-grade lymphoma, including follicular lymphoma, CLL, or small lymphocytic lymphoma to high-grade lymphoma (i.e., diffuse large cell lymphoma) allowed at time of transformation
- Evidence of ≥ 50% bone marrow involvement at the time of enrollment OR tumor tissue accessible for biopsy (for patients enrolled after the maximum tolerated dose \[MTD\] is determined)
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Relapsed or refractory disease
- Willing to undergo serial bone marrow biopsy (for patients enrolled after the MTD is determined)
- No untreated or active CNS leukemia or lymphoma
- Performance status - ECOG 0-2
- At least 12 weeks
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine ≤ 2.0 mg/dL
- No uncontrolled cardiac disease
- No New York Heart Association class III-IV symptomatic congestive heart failure
- No unstable angina pectoris
- No serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation \> 3 beats in a row) within the past 6 months
- No other uncontrolled cardiac arrhythmia or requiring antiarrhythmic drugs
- 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
- QTc ≥ 450 msec (for men) or 470 (for women) on ECG/EKG
- No history of LVEF \< 50% by MUGA or echocardiogram
- Resting ejection fraction ≥ 50% by MUGA or echocardiogram
- No prior history of cardiac toxicity after receiving anthracycline therapy (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, or mitoxantrone hydrochloride)
- No uncontrolled pulmonary disease
- No symptomatic pulmonary disease requiring oxygen or medications
- DLCO (i.e., oxygen diffusion capacity) ≥ 80% on pulmonary function testing
- Resting and exercise oxygen saturation ≥ 90% by pulse oximetry
- No ongoing pulmonary symptoms ≥ grade 2 including any of the following:
- Dyspnea on or off exertion
- Paroxysmal nocturnal dyspnea
- Significant pulmonary disease including chronic obstructive or restrictive pulmonary disease
- No prior history of pulmonary toxicity after bleomycin or carmustine
- No Medicare requirement for home oxygen (e.g., Resting O\_2 saturation ≥ 90% or desaturation to ≥ 90% with exertion)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No preexisting sensory or motor peripheral neuropathy ≥ grade 2
- No history of allergic reaction to eggs
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- Prior stem cell transplantation for relapsed or refractory disease allowed
- At least 2 weeks since prior immunotherapy and recovered
- At least 2 weeks since prior chemotherapy (excluding hydroxyurea) and recovered
- No other concurrent chemotherapy
- No concurrent routine corticosteroids except for treatment of other medical problems (e.g., pulmonary, rheumatologic, or adrenal disorders)
- At least 2 weeks since prior radiotherapy and recovered
- No prior radiotherapy that potentially included the heart in the field (e.g., mantle)
- No prior history of chest radiation
- No concurrent palliative radiotherapy
- At least 2 weeks since prior investigational therapy
- Prior bortezomib allowed
- No other concurrent commercial or investigational agents or therapies for the malignancy
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00103272
Start Date
April 1 2005
Last Update
June 4 2013
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210