phase i/ii study of campath in patients with relapsing or refractory non-hodgkin's lymphoma

Conditions: Non-Hodgkins Lymphoma

Summary: the purpose of this study is to determine the optimal dose of campath for patients with relapsing or refractory (failed standard therapy) non-hodgkin's lymphoma. the study will also evaluate the safety of the drug and whether it is effective in treating these patients.

this study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose (mtd) of campath (alemtuzumab, mabcampath, campath) administered intravenously (iv) once a week as treatment for relapsing or refractory non-hodgkin's lymphoma (nhl). the primary objective of part 2 is to determine the overall response rate (complete response, cr/unconfirmed , plus partial response) of weekly iv campath in the treatment of relapsing or refractory nhl. this is a phase i/ii study, open-label, multicenter study to evaluate the efficacy and safety of weekly iv campath as therapy for patients with relapsing or refractory non-hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: patients must have: * pathologically confirmed diagnosis of relapsing or refractory non-hodgkin's lymphoma that has failed conventional therapy. * measurable disease (lesions that can be accurately measured by ct scan and a greatest transverse diameter larger or equal to 1 cm or palpable lesions that both diameters larger or equal to 2 cm). * life expectancy of at least 12 weeks. - world health organization (who) performance status (ps) of 0, 1, or 2. * adequate marrow and organ function (details are listed in the protocol). * female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy. * signed, written informed consent. exclusion criteria: patients must not have: * prior autologous bone marrow or stem cell transplant within 6 months of study entry. * a history of prior allogeneic bone marrow transplant or organ transplant. * previously untreated non-hodgkin's lymphoma. * previously treated with campath. * patients with bulky disease, ie any single mass \> 7.5cm. * prior radiotherapy to the only site of measurable disease. * medical condition requiring chronic use of oral, high-dose corticosteroids. * autoimmune thrombocytopenia. * use of investigational agents within previous 30 days or any anti-cancer therapy within the previous 3 weeks. patients must have recovered from all acute toxicities of any prior therapy. * past history of anaphylaxis following exposure to humanized monoclonal antibodies. * active, uncontrolled infection, including human immunodeficiency virus (hiv) positive. * active secondary malignancy. * active central nervous system (cns) involvement with nhl. * pregnant or lactating women. male or female patients who do not agree to use effective contraceptive method(s) during the study. * any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.

Keywords: non-hodgkins lymphoma nhl campath alemtuzumab