|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00072514 |
Purpose
This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic Lymphadenopathy Cutaneous B-Cell Non-Hodgkin Lymphoma Mucosa-Associated Lymphoid Tissue Lymphoma Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Monocytoid B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Burkitt's Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin's Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Adult T-cell Lymphoma/Leukaemia Recurrent Cutaneous T-cell Lymphoma Recurrent Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Mantle Cell Lymphoma Recurrent Recurrent Marginal Zone Lymphoma Mycosis Fungoides/Sezary Syndrome Recurrent B-cell Small Lymphocytic Lymphoma Recurrent Small Intestinal Lymphoma Splenic Marginal Zone B-Cell Lymphoma Malignant Lymphoma of Testis Waldenstrom Macroglobulinemia |
Drug: gemcitabine hydrochloride Drug: carboplatin Drug: dexamethasone Biological: rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies |
| Estimated Enrollment: | 54 |
| Study Start Date: | August 2003 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
In Group 1 (CD20-NEGATIVE LYMPHOMAS), patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. In Group 2 (CD20-POSITIVE LYMPHOMAS), patients receive treatment as in group I. Patients also receive rituximab IV on day 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: dexamethasone
Given PO
Other Names:
Biological: rituximab
Given IV in Group 2 only (CD20-POSITIVE LYMPHOMAS)
Other Names:
|
OBJECTIVES:
I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies).
II. To determine the efficacy of the above regimen. III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve).
IV. To determine remission duration.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
GROUP I: CD20-NEGATIVE LYMPHOMAS
GROUP II: CD20-POSITIVE LYMPHOMAS
After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Ajay Gopal | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Gopal, Ajay, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00072514 History of Changes |
| Other Study ID Numbers: | PSOC 2003, NCI-2011-00035 |
| Study First Received: | November 4, 2003 |
| Last Updated: | March 7, 2011 |
| Health Authority: | United States: Federal Government |
|
Burkitt Lymphoma Hodgkin Disease Immunoblastic Lymphadenopathy Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia-Lymphoma, Adult T-Cell Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Mycoses Mycosis Fungoides Sezary Syndrome |
Lymphoma, B-Cell Lymphoma, Large-Cell, Immunoblastic Precursor Cell Lymphoblastic Leukemia-Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Lymphoma, Large-Cell, Anaplastic Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Mantle-Cell Lymphatic Diseases Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |