506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005950
First received: July 5, 2000
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory non-Hodgkin's lymphoma or T-cell lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die


Condition Intervention Phase
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
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: Phase II Study of 506U78 (NSC #686673) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral T-Cell Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate (RR), defined as CR + PR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Failure-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: April 2000
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats 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

Detailed Description:

OBJECTIVES:

I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma when treated with 506U78.

II. Assess the pharmacokinetics and toxicity of this treatment in these patients.

OUTLINE:

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

Patients are followed every 3 months.

  Eligibility

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

Inclusion Criteria:

  • Patients with relapsed or refractory indolent B-cell non-Hodgkin's lymphoma or peripheral T-cell lymphoma

    • Indolent B-cell lymphoma will include Waldenström's macroglobulinemia, lymphoplasmacytoid lymphoma small lymphocytic lymphoma, marginal zone lymphoma, and follicular small cleaved-cell or mixed cell lymphoma; patients with prior or concurrent evidence of transformation to large cell lymphoma or with follicular large cell lymphoma are ineligible
    • Peripheral T-cell lymphoma will include all entities described in the REAL classification; patients with B-cell ALCL are ineligible; patients with cutaneous T-cell lymphoma and all its variants and/or histologic transformation of cutaneous T-cell lymphoma are not eligible for this protocol, because they will be instead eligible for a separate protocol
    • Relapsed peripheral T-cell lymphomas include all those achieving and maintaining a complete or partial response during initial therapy; refractory includes those achieving all other responses during initial therapy; since the response rate of indolent B-cell lymphomas to up-front therapy exceeds 90% this distinction is not meaningful there
  • No more than 2 prior chemotherapy and one prior immunotherapy regimens; if chemoimmunotherapy was used, the limit will be 3 prior regimens
  • Performance status =< 2 Zubrod
  • Staging work-up within 3 weeks and bidimensionally measurable disease
  • No anti-cancer treatment within the past three weeks
  • ANC >= 1,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma
  • Platelets >= 100,000/ul; may be included if in the judgment of the study chairman lower counts are explained by marrow or splenic involvement by lymphoma
  • Bilirubin =< 1.5 x normal
  • SGPT =< 2.5 x normal values
  • Estimated endogenous creatinine clearance > 50 ml/min
  • HIV negative; the patients are excluded because the expected opportunistic infections will render study toxicity difficult to interpret; in addition the possible effects of 506U78 on CD4 cells may be dangerous to these patients; furthermore, indolent B-cell lymphomas and aggressive peripheral T-cell lymphomas are extremely rare in the setting of HIV infection
  • No active CNS disease
  • No other malignancy within the last 5 years, except basal cell carcinoma of the skin or in-situ cervical carcinoma treated with curative intent
  • Females must not be pregnant or breast feeding and must be practicing adequate contraception; this is because 506U78 may be harmful to the developing fetus and nursing newborn or infant
  • No preexisting sensory or motor neuropathy of grade ≥ 2, no history of seizures
  • No prior stem cell or bone marrow transplantation; no prior 506U78
  • All patients, including women or members of a minority that fulfill criteria for study entry will be eligible for treatment; no one fulfilling all these criteria for entry will be denied treatment solely on the basis of sex or minority status
  • Patients with medical, psychiatric, or social conditions that make compliance with treatment or follow-up unlikely are not eligible
  • No history of symptomatic cardiac dysfunction or pericardial effusion
  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: NCT00005950

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005950     History of Changes
Other Study ID Numbers: NCI-2012-02339, ID99-208, N01CM17003, CDR0000067894
Study First Received: July 5, 2000
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, B-Cell, Marginal Zone
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Leukemia, Lymphoid
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 28, 2014