506U78 in Treating Patients With Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005080
First received: April 6, 2000
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die


Condition Intervention Phase
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Small Intestine Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Drug: nelarabine
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: A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Remission rate (complete and partial remission) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Remission duration [ Time Frame: From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years ] [ Designated as safety issue: No ]
    Remission duration will be estimated using the method of Kaplan Meier.

  • Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: May 2000
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nelarabine
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.
Drug: nelarabine
Given IV
Other Names:
  • 506U78
  • Arranon
  • GW506U78

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78.

II. Determine the safety and toxicity of this treatment regimen in this patient population.

OUTLINE:

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including:

    • Mycosis fungoides/Sezary syndrome
    • Peripheral T-Cell lymphomas (medium, mixed medium-large, large cell)
    • Variants of peripheral T-Cell lymphoma
    • Angioimmunoblastic T-Cell lymphoma (AILD); angiocentric lymphoma; intestinal T-Cell Lymphoma; adult T-Cell lymphoma/leukemia (ATLL); anaplastic Large Cell (CD30+) lymphoma, T-cell type Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible; Note: patients diagnosed more than one year prior to entry on this protocol must have a repeat lymph node biopsy. In the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required
  • Biopsy and immunophenotyping should be performed to document relapse after prior treatment
  • CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, and fusion toxins
  • PTCL patients may have failed only one or two prior treatment regimens (one of which may include peripheral stem cell transplantation)
  • Patients must have measurable disease; patients with CTCL must have skin lesions which are measurable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure

    • The following lesions are not considered measurable:

      • Barium studies
      • Ascites or pleural effusion
      • Bony disease (lesions if present should be noted)
      • Bone marrow
  • No CNS lymphoma requiring intrathecal or craniospinal radiation therapy
  • No history of a seizure disorder or grade 3 neurologic toxicity during prior treatment of lymphoma. Baseline neurologic status of all eligible patients is to be carefully recorded (particularly in elderly patients and those with conditions potentially predisposed to neurotoxicity, such as diabetes mellitus and prior exposure to neurotoxic agents); patients with prior neurologic dysfunction or toxicity from any cause must have recovered to grade 1 neurologic toxicity/dysfunction
  • Performance status 0-2
  • No known HIV disease; patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus; patients who test positive or who are known to be infected are not eligible; an HIV test is not required for entry on protocol, but is required if the patient is perceived to be at risk
  • Calculated Creatinine Clearance >= 50 ml/min

    • Unless attributable to lymphoma
    • To be calculated by method of Cockcroft-Gault
  • Bilirubin >= 1.5 x upper limit of normal

    • Patients with hepatic dysfunction should enroll on CALGB 69803
  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: NCT00005080

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Myron Czuczman Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005080     History of Changes
Other Study ID Numbers: NCI-2012-02324, CALGB-59901, U10CA031946, CDR0000067687
Study First Received: April 6, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycosis Fungoides
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Mycoses
Sezary Syndrome
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell, Peripheral
Lymphoma, Large-Cell, Anaplastic
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid

ClinicalTrials.gov processed this record on August 18, 2014