Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT00262860
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00262860
Study Brief:
Protocol Section:
NCT00262860