NCT00968461

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 treated with fludarabine. The safety of PEITC will also be studied.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
3.7 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

August 28, 2009

Last Update Submit

April 12, 2013

Conditions

LeukemiaLymphoproliferative Disorders

Keywords

Chronic lymphocytic leukemiaCLLPEITCPhenethyl IsothiocyanateFludarabine

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    28 Day Cycle

Study Arms (1)

Phenethyl Isothiocyanate (PEITC)

EXPERIMENTAL

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)

Interventions

Phenethyl Isothiocyanate (PEITC)DRUG

Starting dose 40 mg capsules by mouth, 4 times a day, on Days 1-3 and 8-10 of each cycle.

Phenethyl Isothiocyanate (PEITC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

LeukemiaLymphoproliferative DisordersLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

phenethyl isothiocyanate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Apostolia M. Tsimberidou, MD, PHD

    UT MD Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

May 1, 2013

Primary Completion

May 1, 2015

Last Updated

April 15, 2013

Record last verified: 2013-04