Status:
TERMINATED
17-N-Allylamino-17-Demethoxygeldanamycin With or Without Rituximab in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Prolymphocytic 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 when given with or without rituximab in treating patients with relapsed B-cell chronic lymphoc...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of twice weekly 17-allylamino-17-demethoxygeldanamycin (17-AAG) in combination with weekly rituximab in patients with relapsed chr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed B-cell chronic lymphocytic leukemia or prolymphocytic leukemia requiring treatment, defined by 1 of the following criteria:
- Massive or progressive splenomegaly and/or lymphadenopathy
- Anemia (hemoglobin \< 11 g/dL) OR thrombocytopenia (platelet count \< 100,000/mm\^3)
- Weight loss \> 10% within the past 6 months
- Grade 2 or 3 fatigue
- Fevers \> 100.5°F or night sweats for \> 2 weeks with no evidence of infection
- Progressive lymphocytosis with an increase of \> 50% over a 2 month period OR an anticipated doubling time of \< 6 months
- Relapsed disease
- Failed prior fludarabine or pentostatin therapy OR cannot receive fludarabine
- Lymphocyte count ≥ 5,000/mm\^3
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL
- LVEF \> 40% by MUGA
- QTc \< 450 msec for male patients and \< 470 msec for female patients
- Resting ejection fraction ≥ 50% by MUGA or echocardiogram
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No significant cardiac disease including any of the following:
- New York Heart Association class III or IV heart failure
- History of myocardial infarction within the past year
- History of uncontrolled dysrhythmias
- Active ischemic heart disease within the past year
- Poorly controlled angina
- No history of serious ventricular arrhythmia (e.g., ventricular fibrillation, history of symptomatic or sustained ventricular tachycardia, nonsustained ventricular tachycardia \> 3 beats within the past 6 months)
- No history of cardiac toxicity due to anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, or mitoxantrone hydrochloride)
- No other cardiac symptoms ≥ grade 2
- DLCO (i.e., oxygen diffusion capacity) ≥ 80% by pulmonary function testing
- Resting and exercise oxygen saturation ≥ 90% by pulse oximetry
- No pulmonary symptoms ≥ grade 2
- No history of pulmonary toxicity due to bleomycin or carmustine
- No significant, symptomatic pulmonary disease requiring oxygen or medications
- No ongoing pulmonary symptoms ≥ grade 2 including any of the following:
- Dyspnea on or off exertion
- Paroxysmal nocturnal dyspnea
- Significant pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease)
- No Medicare requirements for home oxygen (e.g., resting O\_2 saturations ≥ 90% or desaturation to ≥ 90% with exertion)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to 17-N-allylamino-17-demethoxygeldanamycin
- No history of serious allergic reaction to eggs
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness that would preclude study participation
- More than 3 months since prior rituximab and recovered
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy that potentially included the heart in the field (e.g., mantle)
- No history of chest radiation
- No concurrent medications that prolong or may prolong QTc
- No concurrent antiarrhythmic drugs
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00098488
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