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| Sponsor: | Inex Pharmaceuticals |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006383 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: vincristine sulfate liposomes |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy |
| Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma including:
Diffuse large B-cell lymphoma including:
Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| United States, Illinois | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| University of Texas Health Center at Tyler | |
| Tyler, Texas, United States, 75708 | |
| United States, Vermont | |
| Vermont Cancer Center | |
| Burlington, Vermont, United States, 05401-3498 | |
| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Study Chair: | Barbara Gallimore, PhD | Inex Pharmaceuticals |
More Information
| Study ID Numbers: | CDR0000068259, INEX-CA99002, UCLA-0002028 |
| Study First Received: | October 4, 2000 |
| Last Updated: | November 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006383 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult T-cell leukemia/lymphoma anaplastic large cell lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vincristine Antimitotic Agents Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Tubulin Modulators Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Lymphoma |