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

NCT ID: NCT00061880

Last Updated: 2013-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2008-01-31

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

forodesine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioCryst Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alex Shalaurov, MD, PhD

Role: STUDY_CHAIR

Inveresk Research Group, Incorporated

Locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

CDR0000301763

Identifier Type: REGISTRY

Identifier Source: secondary_id

BIOCRYST-1777BC-103

Identifier Type: -

Identifier Source: org_study_id