Lymphoma
Conditions
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
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States