Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	18 and over	Pharmaceutical / Industry	BIOCRYST-1777BC-103 NCT00061880

Objectives

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• At least 3 months

Hematopoietic

• Granulocyte count at least 2,000/mm³
• Platelet count at least 75,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

BioCryst Pharmaceuticals, Incorporated

Alex Shalaurov, MD, PhD, Protocol chair		Ph: 919-462-2274

Registry Information
Official Title		Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients with Refractory Cutaneous T-Cell Lymphoma (CTCL)
Trial Start Date		2003-02-28
Trial Completion Date		2005-01-31
Registered in ClinicalTrials.gov		NCT00061880
Date Submitted to PDQ		2003-04-02
Information Last Verified		2004-07-26

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