Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab. II. Determine the tolerability of this regimen in these patients by assessing toxicity. SECONDARY OBJECTIVES: I. Determine the time to disease progression and overall survival of patients treated with this regimen. II. Determine the duration of response in patients treated with this regimen. OUTLINE: Patients are stratified according to prior response to rituximab (sensitive \[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last treatment with rituximab alone or in combination with chemotherapy\] vs refractory \[stable or progressive disease OR a PR or CR that lasted \< 6 months after the last treatment with rituximab alone or in combination with chemotherapy\]). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
