mdx-060 monoclonal antibody in treating patients with refractory or relapsed lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies such as mdx-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. purpose: phase i/ii trial to study the effectiveness of mdx-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.

objectives: * determine the safety and tolerability of mdx-060 monoclonal antibody in patients with refractory or relapsed cd30-positive lymphoma. * determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients. * determine the pharmacokinetic profile of this drug in these patients. * determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients. outline: this is an open-label, multicenter, dose-escalation study. patients receive mdx-060 monoclonal antibody iv over 90 minutes once weekly for 4 weeks. cohorts of 3-6 patients receive escalating doses of mdx-060 monoclonal antibody until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined, an additional 16 patients are accrued and receive mdx-060 monoclonal antibody at the mtd. patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression. projected accrual: a maximum of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed b-cell or t-cell lymphoma * hodgkin's lymphoma and anaplastic large cell lymphoma eligible * no hiv-associated lymphoma * cd30-positive disease by biopsy, flow cytometry, or immunohistochemistry * at least 50% of malignant cells (specifically reed-sternberg cells for hodgkin's lymphoma) must express cd30 * must meet one of the following criteria for relapsed/refractory disease: * relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate) * relapsed disease must be within the prior irradiated field * disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option * disease progression must be within the prior irradiated field * progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined) patient characteristics: age * over 12 performance status * ecog 0-2 life expectancy * at least 12 weeks hematopoietic * wbc at least 1,500/mm\^3\* * neutrophil count at least 1,000/mm\^3\* * platelet count at least 75,000/mm\^3\* * hemoglobin at least 8.0 g/dl\* note: \*laboratory abnormalities attributable to organ involvement by lymphoma are allowed hepatic * ast no greater than 2 times upper limit of normal (uln)\* * bilirubin no greater than 2.0 mg/dl (unless due to gilbert's syndrome)\* * hepatitis b surface antigen negative * hepatitis c antibody negative note: \*laboratory abnormalities attributable to organ involvement by lymphoma are allowed renal * creatinine no greater than 2 times uln\* note: \*laboratory abnormalities attributable to organ involvement by lymphoma are allowed other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective barrier contraception during and for 9 months after study participation * hiv negative * no other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * no active significant infection * no apparent opportunistic infection, as indicated by any of the following: * purified protein derivative recently determined to be positive * infectious infiltrate by chest x-ray * recent changes in fever/chill patterns * new, unexplained neurological symptoms * no underlying medical condition that would preclude receiving study therapy prior concurrent therapy: biologic therapy * see disease characteristics * no prior anti-cd30 antibody therapy * no other concurrent biologic therapy chemotherapy * see disease characteristics * at least 4 weeks since prior chemotherapy * no concurrent chemotherapy endocrine therapy * no concurrent systemic steroidal therapy (excluding physiologic doses) radiotherapy * see disease characteristics * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy surgery * not specified other * no other concurrent investigational agents

Keywords: recurrent adult hodgkin lymphoma recurrent/refractory childhood hodgkin lymphoma anaplastic large cell lymphoma recurrent adult diffuse large cell lymphoma recurrent childhood large cell lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma