Study of Phenethyl Isothiocyanate in Lymphoproliferative Disorders
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00968461
First received: August 28, 2009
Last updated: April 12, 2013
Last verified: April 2013
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Purpose
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 |
|---|---|---|
|
Leukemia Lymphoproliferative Disorders |
Drug: Phenethyl Isothiocyanate (PEITC) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: Yes ]
| 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968461 History of Changes |
| Other Study ID Numbers: | 2007-0622 |
| Study First Received: | August 28, 2009 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Chronic lymphocytic leukemia CLL PEITC Phenethyl Isothiocyanate Fludarabine |
Additional relevant MeSH terms:
|
Leukemia Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Phenethyl isothiocyanate |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013