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

Phase 2

Terminated

• Conditions: 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
• Interventions: Drug: nelarabine

• Registration Number: NCT00005950
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-07-05
• Study First Submitted QC: 2004-04-19
• Study First Posted: 2004-04-20
• Primary Completion: 2004-10
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	nelarabine	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.

Primary Outcome Measures

Name	Time	Method
Response rate (RR), defined as CR + PR	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Failure-free survival	Up to 5 years

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States