Status:
COMPLETED
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders
Lead Sponsor:
Vion Pharmaceuticals
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (p...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
- CLL in transformation allowed
- Richter syndrome
- Other refractory lymphoproliferative diseases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Creatinine ≤ 2.0 mg/dL
- Renal dysfunction due to organ infiltration by disease allowed
- AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
- Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No symptomatic coronary artery disease
- No arrhythmia not controlled by medication
- No uncontrolled, symptomatic congestive heart failure
- No myocardial infarction within the past 3 months
- No other uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
- No other concurrent standard or investigational treatment for this cancer
- No other concurrent cytotoxic investigational drugs
- No concurrent disulfiram
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00304005
Start Date
July 1 2005
End Date
August 1 2008
Last Update
July 18 2013
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009