SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: polyamine analogue PG11047 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2006 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Investigator: | Barbara Hicks | Progen Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Hicks, Progen Pharmaceuticals Limited |
| ClinicalTrials.gov Identifier: | NCT00293488 History of Changes |
| Other Study ID Numbers: | CDR0000463738, PROGEN-SL002, UCSF-H1956-21906-02, UCSF-SL002 |
| Study First Received: | February 16, 2006 |
| Last Updated: | September 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
N(1),N(11)-diethylnorspermine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013