Status:
WITHDRAWN
Study of Phenethyl Isothiocyanate in Lymphoproliferative Disorders
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Lymphoproliferative Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to learn the highest tolerable dose of phenethyl isothiocyanate (PEITC) that can be given to patients who have a lymphoproliferative disorder that has been ...
Detailed Description
The Study Drug: PEITC is designed to cause build-up of specific molecules in cells, which may damage cancer cells and cause the cells to die. Study Drug Dose Levels: If you are found to be eligible...
Eligibility Criteria
Inclusion
- All patients with a histologically or cytologically confirmed lymphoproliferative disorder previously treated with fludarabine are eligible for this protocol.
- Patients must be 18 years of age or older.
- Patients must have a performance status of 0-2 (Zubrod scale).
- Patients must have adequate renal function (serum creatinine \</= 2 mg/dL or creatinine clearance \> 50 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
- Patients must have adequate function (bilirubin \</= 2.0 mg/dl; SGOT or SGPT \</= 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder \[for bilirubin\]). Patients with hepatic dysfunction due to organ infiltration by disease may be eligible after discussion with the P.I. and consideration of appropriate dose adjustments.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion
- Untreated or uncontrolled life-threatening infection (Grade 4 infection, i.e. septic shock, hypotension, acidosis, necrosis).
- Pregnancy or breastfeeding. Female patients of childbearing potential (including those \<1 year postmenopausal) and male patients must agree to use contraception. A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Chemotherapy and/or radiation therapy within 4 weeks of study enrollment.
- Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00968461
Start Date
May 1 2013
Last Update
April 15 2013
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