Clinical trial NCT00293488: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Keywords: 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
Lead sponsor: Progen Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: Progen Pharmaceuticals
name: Barbara Hicks
References: