Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Bayside Health Investigator initiated study |
---|---|
Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00163761 |
This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma Hodgkin's Disease |
Drug: gemcitabine, vinorelbine, ifosfamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study |
Official Title: | A Multicentre Phase II Study of Risk-Adjusted Outpatient-Based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma |
Estimated Enrollment: | 90 |
Study Start Date: | December 2002 |
Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of ‘salvage chemotherapy’ treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Australia, Australian Capital Territory | |
Canberra Hospital | |
Canberra, Australian Capital Territory, Australia, 2605 | |
Australia, New South Wales | |
Royal North Shore Hospital | |
Sydney, New South Wales, Australia, 2065 | |
Australia, Queensland | |
Mater Adult Hospital | |
South Brisbane, Queensland, Australia, 4101 | |
Australia, Tasmania | |
Royal Hobart Hospital | |
Hobart, Tasmania, Australia, 7001 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
The Royal Melbourne Hospital | |
Melbourne, Victoria, Australia, 3050 | |
Border Medical Oncology | |
Wodonga, Victoria, Australia, 3690 | |
Frankston Hospital | |
Melbourne, Victoria, Australia, 3199 | |
Monash Medical Centre | |
Melbourne, Victoria, Australia, 3199 | |
Australia, Western Australia | |
Fremantle Hospital | |
Fremantle, Western Australia, Australia, 6160 |
Study Chair: | Andrew Spencer, Assoc. Prof | Unaffiliated |
Study ID Numbers: | AH226/02 |
Study First Received: | September 11, 2005 |
Last Updated: | September 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00163761 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 |
Ifosfamide Vinorelbine Radiation-Sensitizing Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Gemcitabine Antineoplastic Agents, Phytogenic Lymphoma Hodgkin Disease Isophosphamide mustard |
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 |