Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
18 Years
N/A
Both
Lymphoma
Trial Information
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Alex Shalaurov, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Inveresk Research Group, Incorporated
Authority:
United States: Federal Government
Study ID:
BIOCRYST-1777BC-103
NCT ID:
NCT00061880
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
Name | Location |
|---|---|
| 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 |
