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