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506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005982
First received: July 5, 2000
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma


Condition Intervention Phase
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
 Drug: nelarabine
Other: pharmacological study
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

Drug Information available for: Nelarabine
U.S. FDA Resources

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

Primary Outcome Measures:
  • Response rate (RR) defined as CR + PR rates [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2000
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (nelarabine)
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
 Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.

II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma

    • Large cell transformation of cutaneous T-cell lymphoma allowed
  • No active CNS disease
  • Performance status - Zubrod 0-2
  • Absolute neutrophil count at least 1,000/mm^3*
  • Platelet count at least 100,000/mm^3*
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 2.5 times ULN
  • Creatinine clearance greater than 50 mL/min
  • No history of symptomatic cardiac dysfunction
  • No history of pericardial effusion
  • HIV negative
  • No grade 2 or greater sensory or motor neuropathy
  • No history of seizures
  • No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
  • No medical, psychiatric, or social condition that would preclude study
  • No other concurrent serious illness or active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior stem cell or bone marrow transplantation (BMT)
  • No more than 1 prior immunotherapy regimen
  • No more than 3 prior systemic regimens with denileukin diftitox
  • At least 3 weeks since prior biologic therapy
  • No concurrent BMT
  • No prior 506U78

  • No more than 3 prior systemic chemotherapy regimens comprising any of the following:

    • Oral methotrexate
    • Topical mechlorethamine
  • At least 3 weeks since prior chemotherapy
  • No other concurrent chemotherapy
  • At least 3 weeks since prior anticancer endocrine therapy
  • No concurrent topical or systemic steroids
  • At least 3 weeks since prior radiotherapy

  • No more than 3 prior systemic regimens comprising any of the following:

    • Total skin electron beam therapy
    • Spot radiotherapy

  • No more than 3 prior systemic regimens comprising any of the following:

    • Oral retinoids
    • Ultraviolet therapy (PUVA)
  • At least 3 weeks since prior anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005982

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andre Goy M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005982     History of Changes
Other Study ID Numbers: NCI-2012-02344, ID99-213, CDR0000067970
Study First Received: July 5, 2000
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013