SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: polyamine analogue PG11047


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: polyamine analogue PG11047|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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