SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

June 21, 2016 updated by: Progen Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progen Pharmaceuticals

Collaborators

National Cancer Institute (NCI)

Investigators

  • Barbara Hicks, Progen Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROGEN-SL002
  • CDR0000463738 (Registry Identifier: PDQ (Physician Data Query))
  • UCSF-H1956-21906-02
  • UCSF-SL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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