Status:
COMPLETED
Bortezomib and Gemcitabine in Treating Patients With Relapsed B-Cell Non-Hodgkin Lymphoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways ...
Detailed Description
OBJECTIVES: Primary: I. To evaluate the safety and feasibility of combining VELCADE (bortezomib) with gemcitabine (gemcitabine hydrochloride) in patients with recurrent lymphoma after standard thera...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed intermediate or high grade B-cell Non-Hodgkin lymphoma with primary progressive or relapsed disease
- Patients may have had up to 4 prior chemo-and-or radiation therapy regiments, including one autologous transplant based protocol; any prior therapy (chemotherapy or radiation) must have been completed at least 4 weeks prior to start of this protocol; for prior high-dose chemotherapy with stem cell transplant, a 6-week interval is required; all side effects must have resolved
- Karnofsky performance status \>= 60%
- Life expectancy of greater than 3 months
- Absolute neutrophil count \>= 1,500 mm\^3
- Platelets \>= 50,000 mm\^3
- Total bilirubin =\< 1.5 mg/dl
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \>= 50 mL/min for creatinine levels above institutional normal (calculated or measured)
- Cardiac ejection fraction of \> 40% by echocardiogram or multi gated acquisition (MUGA) scan
- Have no serious or intercurrent medical illness
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study
- Male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion
- Patient has a platelet count of \< 20 x 10\^9/L with 7 days before enrollment
- Patient has an absolute neutrophil count of \< 1.0 x 10\^9/L within 7 days before enrollment
- Patient has a calculated or measured creatinine clearance of \< 30 ml/min with 14 days before enrollment
- Patient has \>= Grade 2 peripheral neuropathy within 14 days before enrollment
- Patient has hypersensitivity to bortezomib, boron, or mannitol
- Female subject is pregnant or breastfeeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients who have had more than 4 prior different chemotherapy regimens will be excluded; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for autologous transplant regimens) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not have previously received VELCADE or gemcitabine
- Patients with active central nervous system (CNS) involvement are not eligible
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Key Trial Info
Start Date :
June 29 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00863369
Start Date
June 29 2005
End Date
June 20 2023
Last Update
March 20 2024
Active Locations (2)
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1
City of Hope Medical Center
Duarte, California, United States, 91010-3000
2
South Pasadena Cancer Center
South Pasadena, California, United States, 91030