SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

Original Study ID : CDR0000463738

Secondary ID : Array

NCT ID : NCT00293488

Brief Title : 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

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.

Source : National Cancer Institute (NCI)

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.

Overall Status : Completed

Start Date : January 2006

Official Title : Phase 1

Phase : Interventional

Study Design : Treatment, Non-Randomized, Open Label

Enrollment : 20

Verification Date : September 2008

First Received Date : February 16, 2006

Trial 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : UCSF Helen Diller Family Comprehensive Cancer Center

City : San Francisco

State : California

Zip Code : 94115

Country : United States

Clinical Trial Name -SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma