Status:
COMPLETED
Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease)
- Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided
- Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters \>= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease
- Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
- Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
- Patients should not have evidence active central nervous system lymphoma
- Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
- Patients should have absolute neutrophil count (ANC) \>= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
- Patients should have platelets \>= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
- Serum bilirubin less than 2 times the upper limit of normal
- Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute
- Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment
- All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
- Must anticipate that patient will complete at least 2 cycles of chemotherapy
Exclusion
- Patients known to be human immunodeficiency virus (HIV) positive
- Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI)
- Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen
- Patients with active hepatitis B virus (HBV) infection or hepatitis
- Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00072514
Start Date
August 1 2003
End Date
November 1 2013
Last Update
June 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109