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| Sponsor: | University of Washington |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00072514 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, carboplatin, and dexamethasone with or without rituximab in treating patients who have relapsed or primary refractory lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: carboplatin Drug: dexamethasone Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies |
| Estimated Enrollment: | 51 |
| Study Start Date: | December 2001 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Stratum I (CD20 negative): Experimental
Patients receive carboplatin IV over 30 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; and oral dexamethasone on days 1-4.
|
Drug: carboplatin
Given IV
Drug: dexamethasone
Given orally
Drug: gemcitabine hydrochloride
Given IV
|
|
Stratum II (CD20 positive): Experimental
Patients receive carboplatin, gemcitabine, and dexamethasone as in stratum I and rituximab IV on day 8.
|
Biological: rituximab
Given IV
Drug: carboplatin
Given IV
Drug: dexamethasone
Given orally
Drug: gemcitabine hydrochloride
Given IV
|
OBJECTIVES:
OUTLINE: This is a pilot study. Patients are stratified according to CD20 expression (negative vs positive).
In both strata, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study within 2-3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or primary refractory lymphoid malignancy, with REAL or WHO classification provided, including the following types:
Bidimensionally measurable disease by CT chest/abdomen/pelvis within 28 days of enrollment
Bone marrow aspirate and biopsy within the past 28 days
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
| Study Chair: | Ajay K. Gopal, MD | Seattle Cancer Care Alliance |
| Investigator: | John Pagel, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Seattle Cancer Care Alliance ( Ajay K. Gopal ) |
| Study ID Numbers: | CDR0000339814, UW-LYM.03.01, PSOC-2003, LILLY-B9E-US-X348 |
| Study First Received: | November 4, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00072514 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic 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 anaplastic large cell lymphoma intraocular lymphoma recurrent mycosis fungoides/Sezary syndrome angioimmunoblastic T-cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
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 Therapeutic Uses Gemcitabine Lymphoma |
Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Rituximab Gastrointestinal Agents Enzyme Inhibitors Carboplatin Immunosuppressive Agents Antiviral Agents Glucocorticoids Pharmacologic Actions Lymphatic Diseases Neoplasms |