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

Primary Purpose

Angioimmunoblastic T-cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nelarabine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate (RR), defined as CR + PR

Secondary Outcome Measures

Failure-free survival

Full Information

First Posted
July 5, 2000
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005950
Brief Title
506U78 in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or T-cell Lymphoma
Official Title
Phase II Study of 506U78 (NSC #686673) for Patients With Relapsed or Refractory Indolent B-Cell or Peripheral T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
April 2000 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nelarabine
Other Intervention Name(s)
506U78, Arranon, GW506U78
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Response rate (RR), defined as CR + PR
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Failure-free survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Goy
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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