Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive T-Cell Leukemias or Lymphomas - Full Text View

Sponsor:	BioCryst Pharmaceuticals
Information provided by:	BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00035022

Purpose

The purpose of this study is to determine if intravenous BCX-1777 can be given safely to improve relapsed or refractory aggressive T-cell leukemias and lymphomas.

Condition	Intervention	Phase
Leukemia, Lymphocytic Lymphoma	Drug: BCX-1777	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I-II Study of Intravenous BCX-1777 in Relapsed or Refractory Aggressive (High Grade) T-Cell Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia Lymphoma

Drug Information available for: Forodesine

U.S. FDA Resources

Further study details as provided by BioCryst Pharmaceuticals:

Estimated Enrollment:	71
Study Start Date:	August 2001
Estimated Study Completion Date:	March 2004

Detailed Description:

Despite the great strides that have been made in improving the outcome with frontline programs of intensive chemotherapy in patients with aggressive T-cell malignancies, the prognosis with relapsed or refractory T-cell leukemias or lymphomas is poor. BCX-1777 is a purine nucleoside phosphorylase (PNP) inhibitor and a potential T-cell target therapy.

The purpose of the phase I portion of the study is to determine the maximum tolerated dose (MTD) of BCX-1777 and the dose to be studied in the phase II portion of the study.

The purpose of the phase II portion of the study is to determine the safety and efficacy of BCX-1777 in patients with relapsed or refractory aggressive T-cell malignancies.

Patients who respond to BCX-1777 or have stable disease may be eligible to receive an additional course of treatment.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previously treated, relapsed or refractory aggressive T-cell malignancies (leukemias and lymphomas) histologically proven with measurable disease.
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
All ages are eligible. Pediatric patients (<15 years of age) are eligible to be treated at a dose level previously tested in adults.
Adequate liver and renal function.
Patients with prior history of stem cell transplant if they meet all other eligibility requirements.
Negative pregnancy test within 72 hours of study treatment in females of childbearing potential.
Life expectancy of at least 2 months.

Exclusion:

Active serious infection not controlled by oral or intravenous antibiotics.
Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator.
Concurrent treatment with other anti-cancer agents.
Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy. Lumbar puncture not required in asymptomatic patients.
Pregnant and/or lactating women; or fertile men or women not willing to use contraception.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035022

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

BioCryst Pharmaceuticals

Investigators

Principal Investigator:

Deborah A. Thomas, M.D.

M.D. Anderson Cancer Center

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00035022 History of Changes
Obsolete Identifiers:	NCT00066235
Other Study ID Numbers:	BC-01-02
Study First Received:	May 2, 2002
Last Updated:	January 12, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioCryst Pharmaceuticals:

Leukemia, Lymphoma, T-Cell

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 12, 2012