Clinical trial · Interventional
Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
NCT00262860CI-TRIAL-00022066completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib, Gemcitabine Hdrochloride
- interventionNames
- Drug: bortezomib
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Response Rate After 2 Courses of Therapy
- timeFrame
- 21 Days/course for up to 2 courses
- description
- 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).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMendler JH, Kelly J, Voci S, Marquis D, Rich L, Rossi RM, Bernstein SH, Jordan CT, Liesveld J, Fisher RI, Friedberg JW. Bortezomib and gemcitabine in relapsed or refractory Hodgkin's lymphoma. Ann Oncol. 2008 Oct;19(10):1759-64. doi: 10.1093/annonc/mdn365. Epub 2008 May 25. PMID 18504251