SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00293488
First received: February 16, 2006
Last updated: September 22, 2008
Last verified: September 2008

February 16, 2006
September 22, 2008
January 2006
September 2008   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00293488 on ClinicalTrials.gov 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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Drug: polyamine analogue PG11047
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00293488
CDR0000463738, PROGEN-SL002, UCSF-H1956-21906-02, UCSF-SL002
Not Provided
Barbara Hicks, Progen Pharmaceuticals Limited
Progen Pharmaceuticals
National Cancer Institute (NCI)
Investigator: Barbara Hicks Progen Pharmaceuticals
National Cancer Institute (NCI)
September 2008

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