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| Sponsored by: |
National Cancer Institute of Canada |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014209 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cisplatin Drug: dexamethasone Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Of Gemcitabine, Dexamethasone, And Cisplatin (GDP) In Patients With Either Hodgkin's Disease Or Aggressive Histology Non-Hodgkin's Lymphoma Which Is Relapsed Or Refractory |
| Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease (Hodgkin's disease vs non-Hodgkin's lymphoma).
Patients receive oral dexamethasone on days 1-4, cisplatin IV over 1 hour on day 1, and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 44-88 patients (22-44 per stratum) will be accrued for this study within 4-10 months.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL)
Bidimensionally measurable disease that is clinically or radiologically documented
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, New Brunswick | |
| Moncton Hospital | |
| Moncton, New Brunswick, Canada, E1C 6ZB | |
| Canada, Newfoundland and Labrador | |
| Newfoundland Cancer Treatment and Research Foundation | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Cancer Care Ontario - Windsor Regional Cancer Centre | |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Credit Valley Hospital | |
| Mississauga, Ontario, Canada, L5M 2N1 | |
| Humber River Regional Hospital | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Northwestern Ontario Regional Cancer Centre, Thunder Bay | |
| Thunder Bay, Ontario, Canada, P7A 7T1 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Study Chair: | Michael R. Crump, MD, FRCPC | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | CDR0000068518, CAN-NCIC-LY10, LILLY-CAN-NCIC-LY10 |
| Study First Received: | April 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00014209 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult Hodgkin lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma anaplastic large cell lymphoma |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Cisplatin Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Aggression Lymphoma, Large-cell |
Gemcitabine Hodgkin Disease Lymphoma Dexamethasone acetate Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Hodgkin Lymphoma, Adult Hodgkin's Disease Immunosuppressive Agents Antiviral Agents Glucocorticoids Recurrence Lymphatic Diseases Radiation-Sensitizing Agents |
|
Antimetabolites Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Cisplatin Therapeutic Uses Gemcitabine |
Lymphoma Hodgkin Disease Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms |