SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

NCT ID: NCT00293488

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

polyamine analogue PG11047

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Progen Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Hicks

Role:

Progen Pharmaceuticals

Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Countries

United States

Other Identifiers

CDR0000463738

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCSF-H1956-21906-02

Identifier Type: -

Identifier Source: secondary_id

UCSF-SL002

Identifier Type: -

Identifier Source: secondary_id

PROGEN-SL002

Identifier Type: -

Identifier Source: org_study_id