CpG 7909, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Treatment
RATIONALE: Biological therapies, such as CpG 7909, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab and yttrium Y-90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving CpG 7909 together with monoclonal antibodies may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of CpG 7909 when given together with rituximab and yttrium Y-90 ibritumomab tiuxetan and to see how well it works in treating patients with non-Hodgkin's lymphoma that is recurrent or did not respond to previous treatment.
Drug: agatolimod sodium
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: yttrium Y 90 ibritumomab tiuxetan
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of CpG 7909, Rituximab Immunotherapy, and Y-90 Zevalin Radioimmunotherapy for Patients With Previously Treated CD20+ Non-Hodgkin Lymphoma|
- Maximum Tolerated Dose of CpG 7909 as Determined Using the Number of Participants With a DLT at Each Dose Level [ Time Frame: at least 10 weeks post treatment up to 3 months. ] [ Designated as safety issue: Yes ]
Participants will be treated in cohorts of 6 patients at each dose level of CpG 7909 (0.08 mg/kg, 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg) and observed for at least 10 weeks post treatment. If at most one of the 6 patients experiences a dose limiting toxicity (DLT), a new cohort of 6 patients will be treated at the next higher dose level. A DLT for this study is defined as patients with one of the following:
- Absolute neutrophil counts or platelet counts below 10*10^9/L for 14 days
- Absolute neutrophil counts greater than 0.5 or less than 1*10^9/L
- Platelet counts greater than 10 or less than 50*10^9/L for 28 days.
- Any grade 3 non-hematologic toxicity not explainable by another obvious cause as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
We are reporting the number of DLTs at each of the dose levels. The maximum tolerated dose will be 0.48 mg/kg or the largest dose level where 1 or fewer participants reports a dose limiting toxicity.
- Tumor Response [ Time Frame: Evaluations occur every three months up to a year ] [ Designated as safety issue: No ]
Complete Response (CR):
- No measurable or nonmeasurable disease.
- No symptoms of Lymphoma.
- Non-palpable spleen, if palpable at baseline.
- Histologically negative bone marrow, if positive at baseline.
- All nodes <1.5 cm in transverse diameter.
Partial Response (PR):
- greater than 50% decrease from baseline in the sum of the products of the longest perpendicular diameters of the six largest dominant lesions.
- No new lesions
We are reporting the number of participants that attained a status of CR or PR.
- Progression-free Survival [ Time Frame: Up to 1 year from treatment start date ] [ Designated as safety issue: No ]The Progression-free survival (PFS) is defined as the time from registration to progression or death due to any cause. The distribution of PFS will be estimated using the method of Kaplan-Meier.
- Duration of Response [ Time Frame: Up to 1 year from treatment start date ] [ Designated as safety issue: No ]Duration of response (DoR) will be calculated from the documentation of response until the date of progression in the subset of patients who respond.
|Study Start Date:||October 2004|
|Study Completion Date:||June 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Phase I patients will receive the following treatment:
Phase II patients will receive the following treatment:
Drug: agatolimod sodium
Other Name: CpG 7909Radiation: indium In 111 ibritumomab tiuxetan Radiation: yttrium Y 90 ibritumomab tiuxetan
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438880
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Thomas E. Witzig, MD||Mayo Clinic|