SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293488
• Other study ID #: PROGEN-SL002
• Secondary ID: CDR0000463738UCS
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2006
• Last updated: June 21, 2016
• Start date: January 2006

Study information

• Verified date: June 2016
• Source: Progen Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• polyamine analogue PG11047

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Progen Pharmaceuticals	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,