SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293488
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : June 23, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Progen Pharmaceuticals

February 16, 2006
February 17, 2006
June 23, 2016
January 2006
September 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00293488 on Archive Site
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SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma

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.



  • 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.


  • 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.

Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: polyamine analogue PG11047
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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September 2008   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000463738 ( Registry Identifier: PDQ (Physician Data Query) )
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Progen Pharmaceuticals
Progen Pharmaceuticals
National Cancer Institute (NCI)
Investigator: Barbara Hicks Progen Pharmaceuticals
Progen Pharmaceuticals
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP