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Study of Phenethyl Isothiocyanate in Lymphoproliferative Disorders

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: August 28, 2009
Last updated: April 12, 2013
Last verified: April 2013
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 treated with fludarabine. The safety of PEITC will also be studied.

Condition Intervention Phase
Lymphoproliferative Disorders
Drug: Phenethyl Isothiocyanate (PEITC)
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Phenethyl Isothiocyanate (PEITC) in Patients With Lymphoproliferative Disorders Previously Treated With Fludarabine

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Day Cycle ]

Enrollment: 0
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phenethyl Isothiocyanate (PEITC)
Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle.
Drug: Phenethyl Isothiocyanate (PEITC)
Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All patients with a histologically or cytologically confirmed lymphoproliferative disorder previously treated with fludarabine are eligible for this protocol.
  2. Patients must be 18 years of age or older.
  3. Patients must have a performance status of 0-2 (Zubrod scale).
  4. 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.
  5. 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.
  6. 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 Criteria:

  1. Untreated or uncontrolled life-threatening infection (Grade 4 infection, i.e. septic shock, hypotension, acidosis, necrosis).
  2. 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).
  3. Chemotherapy and/or radiation therapy within 4 weeks of study enrollment.
  4. 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00968461

Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Apostolia M. Tsimberidou, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00968461     History of Changes
Other Study ID Numbers: 2007-0622
Study First Received: August 28, 2009
Last Updated: April 12, 2013

Keywords provided by M.D. Anderson Cancer Center:
Chronic lymphocytic leukemia
Phenethyl Isothiocyanate

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Phenethyl isothiocyanate
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs processed this record on May 23, 2017