BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma - Full Text View

Sponsor:	BioCryst Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061880

Purpose

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: forodesine hydrochloride	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Forodesine Forodesine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	February 2003
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma.
Determine the efficacy of this drug in these patients.
Determine the toxicity profile of this drug in these patients.
Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug.
Determine the provisional optimal biological dose of this drug in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.

Phase I: Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 (a total of 9 doses). Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients receive treatment as in phase I at the MTD of BCX-1777. Patients (including those who respond to treatment) are followed at 14 and 30 days, monthly for 6 months, every 2 months for 6 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 40 for phase II) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed cutaneous T-cell lymphoma (CTCL)
- Any stage except IA patch only
Previously treated according to 1 of the following:
- Stage IA plaque, IB, or IIA:
  - At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids)
- Stage IIB, III, or IV:
  - At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen
Measurable disease

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-3

Life expectancy

At least 3 months

Hematopoietic

Granulocyte count at least 2,000/mm^3
Platelet count at least 75,000/mm^3
Hemoglobin at least 10.0 g/dL

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
ALT no greater than 2 times ULN
Alkaline phosphatase no greater than 2 times ULN
No hepatitis B or C

Renal

Creatinine clearance at least 45 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
Human T-cell leukemia virus type 1 (HTLV-1) negative
No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No other illness that would limit study participation
No active serious infection not controlled by antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent anticancer antibody therapy
No concurrent anticancer immunotherapy
No concurrent anticancer gene therapy
No concurrent anticancer vaccine therapy
No concurrent anticancer angiogenesis inhibitors
No concurrent sargramostim (GM-CSF)
No concurrent filgrastim (G-CSF) during course 1 of therapy

Chemotherapy

More than 21 days since prior chemotherapy unless fully recovered
No concurrent anticancer chemotherapy

Endocrine therapy

See Disease Characteristics
More than 2 weeks since prior topical corticosteroids
No concurrent anticancer hormonal therapy

Radiotherapy

More than 2 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery

Not specified

Other

More than 2 weeks since prior antineoplastic therapy
More than 21 days since prior investigational agents unless fully recovered
No concurrent citrate-blood products within 30 minutes before or after study treatment
No concurrent anticancer matrix metalloprotease inhibitors
No other concurrent anti-CTCL therapy
No concurrent use of tanning beds
No other concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061880

Locations

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

BioCryst Pharmaceuticals

Investigators

Study Chair:

Alex Shalaurov, MD, PhD

Inveresk Research Group, Incorporated

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000301763, BIOCRYST-1777BC-103
Study First Received:	June 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00061880 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma

recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Lymphoma, T-Cell

Sezary Syndrome
Mycosis Fungoides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 09, 2009