sl-11047 in treating patients with relapsed or refractory lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy, such as sl-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. purpose: this phase i trial is studying the side effects and best dose of sl-11047 in treating patients with relapsed or refractory lymphoma.

objectives: primary * determine the maximum tolerated dose (mtd) of sl-11047 in patients with relapsed or refractory lymphoma. * describe and quantify the toxicity of sl-11047 administered to patients with relapsed or refractory lymphoma. secondary * describe the pharmacokinetics of sl-11047 administered as a 30-minute iv infusion. * assess the response rate and duration of response in patients treated with sl-11047. * assess the level of sl-11047 within tumor tissues following intravenous administration of the drug. * determine the sensitivity of abnormal circulating macrophages to sl-11047. outline: this is an open-label, nonrandomized, dose-escalation study. patients receive sl-11047 iv over 30 minutes on days 1-5. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of sl-11047 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically\* confirmed hodgkin's or non-hodgkin's lymphoma (nhl) of any histology * the following nhl types are eligible: * diffuse large b-cell lymphoma * follicular lymphoma * mantle cell lymphoma * marginal zone lymphoma (including lymphoma of mucosa-associated tissue \[malt\]) * anaplastic large cell lymphoma * peripheral t-cell lymphoma * cutaneous t-cell lymphoma * t/nk cell lymphoma * angioimmunoblastic lymphadenopathy-type t-cell lymphoma * burkitt's lymphoma note: \* if histologic confirmation was made at initial diagnosis, confirmation of relapsed or refractory disease can be made by repeat histologic evaluation or by evidence of regrowth at a site of disease that was previously histologically confirmed * relapsed after or refractory to ≥ 2 prior therapeutic regimens or patient is ineligible to receive potentially curative therapy * bidimensionally measurable or evaluable (e.g., bone marrow or infiltrative organ involvement) disease by physical exam or radiographic study * no suspicion or evidence of lymphomatous meningitis patient characteristics: * life expectancy ≥ 12 weeks * ecog performance status 0-4 * not pregnant * negative pregnancy test * fertile patients must use medically prescribed contraception * absolute neutrophil count ≥ 1,000/mm\^3\* * platelet count ≥ 50,000/mm\^3\* * hemoglobin ≥ 8 g/dl\* * serum creatinine ≤ 2.0 mg/dl * total bilirubin ≤ 2.0 mg/dl\*\* * transaminases \< 5 times upper limit of normal\*\* * no other malignancy within the past 5 years other than curatively treated non-metastatic skin cancer or in situ cervical carcinoma * no history of significant or symptomatic cardiac arrhythmia * no history of myocardial infarction * no significant ventricular conduction abnormality by ecg or holter monitoring, as evidenced by any of the following: * prior myocardial infarction * three or more premature ventricular contractions in a row * no history of pancreatitis * no history of recent gastrointestinal bleeding * must have heme-negative stool at enrollment note: \*cytopenias due to direct lymphomatous involvement allowed note: \*\*elevated due to direct lymphomatous involvement allowed prior concurrent therapy: * see disease characteristics * more than 3 weeks since prior chemotherapy * recovered from prior chemotherapy (alopecia or anemia allowed) * more than 3 weeks since prior investigational drugs * no prophylactic antiemetics during course 1 * no other concurrent investigational drugs

Keywords: anaplastic large cell lymphoma angioimmunoblastic t-cell lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma recurrent adult burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult hodgkin lymphoma recurrent adult t-cell leukemia/lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent mycosis fungoides/sezary syndrome splenic marginal zone lymphoma