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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014