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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00061880
First received: June 5, 2003
Last updated: May 29, 2013
Last verified: July 2004
  Purpose

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 Intervention Phase
Lymphoma
Drug: forodesine hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2003
Study Completion Date: January 2008
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061880

Locations
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
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
Study Chair: Alex Shalaurov, MD, PhD Inveresk Research Group, Incorporated
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00061880     History of Changes
Other Study ID Numbers: BIOCRYST-1777BC-103, CDR0000301763
Study First Received: June 5, 2003
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014