Status:
WITHDRAWN
Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
Lead Sponsor:
University of Miami
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: 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 o...
Detailed Description
OBJECTIVES: Primary * Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:
- Nodular sclerosis
- Mixed cellularity
- Lymphocyte-rich
- Lymphocyte-depleted
- Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
- No known CNS metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC \> 1,500/mm\^3
- Platelet count \> 75,000/mm\^3
- Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active hepatitis B infection
- No known chronic hepatitis B carrier
- No HIV positivity
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic neurological illness
- Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Significant pulmonary disease or hypoxia
- Psychiatric illness or social situation that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered
- No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab
- No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00881387
Start Date
February 1 2009
End Date
October 1 2012
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136