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

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

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


- 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.

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- At least 3 months


- Granulocyte count at least 2,000/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 10.0 g/dL


- 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


- Creatinine clearance at least 45 mL/min


- 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


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


- 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


- More than 2 weeks since prior radiotherapy

- No concurrent radiotherapy


- Not specified


- 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

- No concurrent anticancer matrix metalloprotease inhibitors

- No other concurrent anti-CTCL therapy

- No concurrent use of tanning beds

- No other concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alex Shalaurov, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Inveresk Research Group, Incorporated


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

January 2008

Related Keywords:

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



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