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

Phase 1
18 Years
Not Enrolling

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Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Barbara Hicks

Investigator Affiliation:

Progen Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma



UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115