SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progen Pharmaceuticals
• Collaborator: National Cancer Institute (NCI)
• Treatments: N(1),N(11)-diethylnorspermine

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