Bortezomib and Gemcitabine Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
James P. Wilmot Cancer Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262860
First received: December 6, 2005
Last updated: November 20, 2008
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: bortezomib Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate after 2 courses of therapy [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2005 |
OBJECTIVES:
Primary
- Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262860
Locations
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
James P. Wilmot Cancer Center
Investigators
| Principal Investigator: | Jonathan W. Friedberg, MD | James P. Wilmot Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00262860 History of Changes |
| Other Study ID Numbers: | CDR0000448635, URCC-U9404, URCC-RSRB-10368, MILLENNIUM-VEL-03-079, LILLY-B9E-US-X433, DFCI-04388 |
| Study First Received: | December 6, 2005 |
| Last Updated: | November 20, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Bortezomib Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013