Non Hodgkin Lymphoma Clinical Trial
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed 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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 3 Locations for this study
Rochester Minnesota, 55905, United States
New York New York, 10021, United States
Columbus Ohio, 43210, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.