Bortezomib in Treating Patients With Mantle Cell Lymphoma (NCT00030875) | Clinical Trial Compass
CompletedPhase 2
Bortezomib in Treating Patients With Mantle Cell Lymphoma
Canada30 participantsStarted 2002-11-19
Plain-language summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma
* No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy
* At least 1 bidimensionally measurable disease site\*
* Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR
* Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: \*Bone lesions are not considered bidimensionally measurable disease
* No pre-existing ascites or pleural effusion
* No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST or ALT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* LVEF at least 45% by echocardiogram or MUGA
Pulmonary
* No pre-existing shortness of breath greater than grade 1
Other:
* No uncontrolled bacterial, fungal, or viral infections
* No pre-existing edema greater than grade 1
* No pre-existing neuropathy greater than grade 1
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious illness or medical condition that …