Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Response rate after 2 courses of therapy
Safety Issue:
No
Principal Investigator
Jonathan W. Friedberg, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000448635
NCT ID:
NCT00262860
Start Date:
April 2005
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
