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SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00293488
Enrollment
20
Registered
2006-02-17
Start date
2006-01-31
Completion date
Unknown
Last updated
2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGpolyamine analogue PG11047

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Progen Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026