A Phase 2 interventional study of bortezomib and gemcitabine hydrochloride in Lymphoma, sponsored by University of Rochester. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-05-09.
Sponsored by University of Rochester · Phase 2, Interventional, and Treatment
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 to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, pilot study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Other
Drug: bortezomib · Drug: gemcitabine hydrochloride
Response Rate After 2 Courses of Therapy
Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).
Time frame: 21 Days/course for up to 2 courses
Change in Proteasome Activity Compared to Baseline (Cycle 1)
Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
Time frame: baseline to 2 hours
Change in Proteasome Activity Compared to Baseline (Cycle 2)
Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
Time frame: baseline and 1-2 weeks after cycle 2, day 11
| Milestone | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Started | 18 |
| Completed | 16 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
Response was evaluated after two cycles of therapy using the 1999 Cheson response criteria. All responses were based on CT scans. The criteria that were developed include anatomic definitions of response, with normal lymph node size after treatment of 1.5 cm in the longest transverse diameter by computer-assisted tomography scan. A designation of complete response/unconfirmed was adopted to include patients with a greater than 75% reduction in tumor size after therapy but with a residual mass, to include patients-especially those with large-cell NHL-who may not have residual disease. For patients who had FDG-PET imaging, metabolic response was defined as a decrease in the standardized uptake value in target lesions (regions of abnormal FDG uptake on pretreatment FDG-PET images) to below three on posttreatment FDG-PET imaging). All PET scans were reviewed and interpreted by a single radiologist (SV).
| participants | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Response Rate After 2 Courses of Therapy | 4 |
Peripheral blood (40 ml) was collected on cycle 1, day 1 of prebortezomib at baseline and 2 hrs post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
| Percentage of change in proteosome activ | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Change in Proteasome Activity Compared to Baseline (Cycle 1) | -50 (-77 to 39) |
Peripheral blood (40 ml) was collected at baseline and 1-2 weeks after cycle 2, day 11 post-bortezomib treatment. The samples were refrigerated at 4C and processed within 36 h of collection. Frozen cell lysates were thawed and the proteasome activity in 10 microliters was determined using a spectroflourometric 20S proteasome assay kit. Samples were run in triplicate on two separate days. The percent change between baseline and 2 hrs (day1, cycle 1) was calculated.
| percentage of change in proteosome activ | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Change in Proteasome Activity Compared to Baseline (Cycle 2) | -57 (-92 to 223) |
Collected over days 1 and 8 of each cycle of therapy, up to 2 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bortezomib, Gemcitabine Hydrochloride | — | 5/18 (27.8%) | 18/18 (100%) |
| Event | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| neutropeniaBlood and lymphatic system disorders | 5/18 |
| leukopeniaBlood and lymphatic system disorders | 3/18 |
| elevated transaminasesHepatobiliary disorders | 3/18 |
| thrombocytompeniaBlood and lymphatic system disorders | 2/18 |
| hyperglycemiaVascular disorders | 1/18 |
| abdominal pain/crampsGeneral disorders | 1/18 |
| lymphopeniaBlood and lymphatic system disorders | 1/18 |
| headache/migraineNervous system disorders | 1/18 |
| sepsisInfections and infestations | 1/18 |
| DVT near lineVascular disorders | 1/18 |
| Event | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| thrombocytopeniaBlood and lymphatic system disorders | 8/18 |
| anemiaBlood and lymphatic system disorders | 8/18 |
| leukopeniaBlood and lymphatic system disorders | 7/18 |
| painGeneral disorders | 7/18 |
| hypocalcemiaBlood and lymphatic system disorders | 6/18 |
| neutropeniaBlood and lymphatic system disorders | 5/18 |
| elevated transaminasesHepatobiliary disorders | 4/18 |
| hyperglycemiaEndocrine disorders | 3/18 |
| abdominal pain/crampsGastrointestinal disorders | 2/18 |
| Age, Continuous(years) | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Median | 36 (19 to 62) |
| Sex: Female, Male(Participants) | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| Female | 10 |
| Male | 8 |
| Race/Ethnicity, Customized(participants) | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| White | 16 |
| Black | 2 |
| Region of Enrollment(participants) | Bortezomib, Gemcitabine Hydrochloride |
|---|---|
| United States | 18 |
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