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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
forodesine hydrochloride
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Duke Comprehensive Cancer Center
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
May 29, 2013
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00061880
Brief Title
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Official Title
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
forodesine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Shalaurov, MD, PhD
Organizational Affiliation
Inveresk Research Group, Incorporated
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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

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