Status and phase
Conditions
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Study type
Funder types
Identifiers
About
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.
Full description
OBJECTIVES:
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell or T-cell lymphoma
CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
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)
Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
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:
No underlying medical condition that would preclude receiving study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Data sourced from clinicaltrials.gov
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