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Sponsors and Collaborators: |
Bayside Health Investigator initiated study |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00163748 |
This is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. Participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma Hodgkin's Disease |
Drug: gemcitabine, vinorelbine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma. |
Estimated Enrollment: | 40 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | November 2003 |
Patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. The standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. However, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). Currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). Two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. Furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. All the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Australia, New South Wales | |
Royal North Shore Hospital | |
Sydney, New South Wales, Australia, 2065 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 |
Study Chair: | Andrew Spencer, Assoc. Prof | Unaffiliated |
Study ID Numbers: | AH152/00 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00163748 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Lymphoma |
Antimetabolites Anti-Infective Agents Immunoproliferative Disorders Immunologic Factors Hodgkin Lymphoma, Adult Hodgkin's Disease Immunosuppressive Agents Antiviral Agents Lymphoma, Small Cleaved-cell, Diffuse |
Lymphatic Diseases Vinorelbine Radiation-Sensitizing Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Gemcitabine Antineoplastic Agents, Phytogenic Lymphoma Hodgkin Disease |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Therapeutic Uses Gemcitabine Lymphoma Hodgkin Disease Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Vinorelbine Radiation-Sensitizing Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic |