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

Lymphoma Clinical Trial

Official title:

Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061880
• Other study ID #: BIOCRYST-1777BC-103
• Secondary ID: CDR0000301763
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 5, 2003
• Last updated: May 29, 2013
• Start date: February 2003
• Est. completion date: January 2008

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• forodesine hydrochloride

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
BioCryst Pharmaceuticals

Country where clinical trial is conducted

United States,