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Sponsors and Collaborators: |
Progen Pharmaceuticals Limited National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293488 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
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
Secondary
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.
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:
PATIENT CHARACTERISTICS:
No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following:
No history of recent gastrointestinal bleeding
NOTE: **Elevated due to direct lymphomatous involvement allowed
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Investigator: | Barbara Hicks | Progen Pharmaceuticals Limited |
Responsible Party: | Progen Pharmaceuticals Limited ( Barbara Hicks ) |
Study ID Numbers: | CDR0000463738, PROGEN-SL002, UCSF-H1956-21906-02, UCSF-SL002 |
Study First Received: | February 16, 2006 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00293488 |
Health Authority: | United States: Food and Drug Administration |
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 |
Sezary syndrome Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoma, large-cell Lymphoma, B-Cell Burkitt's lymphoma Leukemia Mycoses |
Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Immunoblastic Lymphadenopathy Mantle cell lymphoma Recurrence Lymphatic Diseases B-cell lymphomas Burkitt Lymphoma Leukemia, T-Cell Anaplastic large cell lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |