---
title: SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
nct_id: NCT00293488
overall_status: COMPLETED
phase: PHASE1
sponsor: Progen Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Lymphoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00293488.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00293488"
ct_last_update_post_date: 2016-06-23
last_seen_at: "2026-05-12T07:01:27.207Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

**Official Title:** An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma

**NCT ID:** [NCT00293488](https://clinicaltrials.gov/study/NCT00293488)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Progen Pharmaceuticals
- **Collaborators:** National Cancer Institute (NCI)
- **Conditions:** Lymphoma
- **Start Date:** 2006-01
- **CT.gov Last Update:** 2016-06-23

## Brief Summary

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.

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 120 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **polyamine analogue PG11047** (DRUG)

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ucsf helen diller family comprehensive cancer center|san francisco|california|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00293488*  
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