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
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: polyamine analogue PG11047
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: January 2006
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293488

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
Progen Pharmaceuticals
Investigators
Investigator: Barbara Hicks Progen Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Hicks, Progen Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00293488     History of Changes
Other Study ID Numbers: CDR0000463738, PROGEN-SL002, UCSF-H1956-21906-02, UCSF-SL002
Study First Received: February 16, 2006
Last Updated: September 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
N(1),N(11)-diethylnorspermine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014