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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00061880
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : May 30, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

June 5, 2003
June 6, 2003
May 30, 2013
February 2003
January 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00061880 on ClinicalTrials.gov Archive Site
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BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)

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.

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.

Interventional
Phase 1
Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
Drug: forodesine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2008
January 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00061880
BIOCRYST-1777BC-103
CDR0000301763 ( Registry Identifier: PDQ (Physician Data Query) )
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BioCryst Pharmaceuticals
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Study Chair: Alex Shalaurov, MD, PhD Inveresk Research Group, Incorporated
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP