Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell… (NCT00031642) | Clinical Trial Compass
CompletedPhase 1/2
Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation
United States26 participantsStarted 2002-01-01
Plain-language summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances.
PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.
Who can participate
Age range19 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation
* Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks
o Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis
* CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following:
* Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
* Flow cytometry studies
* Measurable disease
o More than 2 cm bidimensionally
* 19 years of age and over
* Performance status WHO 0-2
* Life expectancy at least 3 months
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 150,000/mm\^3
* Bilirubin less than 2.0 mg/dL
* SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver)
* Creatinine less than 2.0 mg/dL
* Fertile patients must use effective contraception during and for 6 months after study therapy
* HIV negative
* At least 4 weeks since prior growth factors
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
* At least 4 weeks since prior radiotherapy
* Recovered from all prior therapy
* At least 4 weeks since prior immunosuppressants
Exclusion Criteria:
* No active CNS lymphoma
* No HIV- or AIDS-rela…