Phase 2
N=18
Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00262860 ↗Enrolled (actual)
18
Serious AEs
27.8%
Results posted
Mar 2016
Primary outcome: Primary: Response Rate After 2 Courses of Therapy — 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bortezomib (Drug); gemcitabine hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate After 2 Courses of Therapy |
4 | — |
| SECONDARY Change in Proteasome Activity Compared to Baseline (Cycle 1) |
-50 | — |
| SECONDARY Change in Proteasome Activity Compared to Baseline (Cycle 2) |
-57 | — |
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 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed Hodgkin's lymphoma
- Recurrent or refractory disease after prior standard combination chemotherapy
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 1 cm by physical exam or imaging studies
- No history of non-Hodgkin's lymphoma
- No history of other hematological malignancy
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN) (unless due to Gilbert's disease or involvement by Hodgkin's lymphoma)
- AST ≤ 3 times ULN (unless due to involvement by Hodgkin's lymphoma)
Renal
- Creatinine clearance ≥ 30 mL/min
Cardiovascular
- Ejection fraction ≥ 40% by MUGA or echocardiogram (in patients with a history of cardiac disease)
Pulmonary
- Must not require supplemental oxygen therapy
Immunologic
- No known HIV infection
- No uncontrolled bacterial, viral, or fungal infection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy requiring therapy
- No peripheral neuropathy ≥ grade 2 within the past 14 days
- No hypersensitivity to boron
- No hypersensitivity to mannitol
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 30 days since prior monoclonal antibody therapy for Hodgkin's lymphoma
- More than 6 months since prior autologous stem cell transplantation
- No prior allogeneic stem cell transplantation
- No concurrent sargramostim (GM-CSF)
- No concurrent pegfilgrastim or filgrastim (G-CSF)
- No concurrent interleukin-11(oprelvekin)
Chemotherapy
- See Disease Characteristics
- More than 30 days since prior chemotherapy for Hodgkin's lymphoma
- No prior treatment with gemcitabine hydrochloride
Endocrine therapy
- More than 30 days since prior corticosteroid therapy for Hodgkin's lymphoma
- No concurrent corticosteroid therapy
Radiotherapy
- More than 30 days since prior radiotherapy for Hodgkin's lymphoma
Other
- No prior treatment with bortezomib
- More than 14 days since prior investigational drugs
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00262860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.