Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:
CD20+ disease
Measurable progressive or refractory disease
No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
SGOT and SGPT no greater than 1.5 times upper limit of normal
Bilirubin normal
No liver disease
Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 30 days since other prior investigational drugs
More than 30 days since prior immunosuppressive medications
No concurrent immunosuppressive medications including the following:
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal