BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT00061880 |
Recruitment Status :
Completed
First Posted : June 6, 2003
Last Update Posted : May 30, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma | Drug: forodesine hydrochloride | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL) |
Study Start Date : | February 2003 |
Actual Primary Completion Date : | January 2005 |
Actual Study Completion Date : | January 2008 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed cutaneous T-cell lymphoma (CTCL)
- Any stage except IA patch only
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Previously treated according to 1 of the following:
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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)
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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
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- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061880
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Alex Shalaurov, MD, PhD | Inveresk Research Group, Incorporated |
ClinicalTrials.gov Identifier: | NCT00061880 |
Other Study ID Numbers: |
BIOCRYST-1777BC-103 CDR0000301763 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | June 6, 2003 Key Record Dates |
Last Update Posted: | May 30, 2013 |
Last Verified: | July 2004 |
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 Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |