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Phase I Study of CpG 7909 and Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase I | Treatment | Closed | 18 and over | UCLA-0112032 CPGI-C004-CPG7909, NCI-G02-2086, NCT00040950 |
Objectives - Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered with rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the disease response in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
- CD20 positive by immunohistochemistry or flow
cytometry
- Relapsed or refractory disease
- Bidimensionally measurable disease
- Sole site of measurable disease within a previously
irradiated field allowed
provided there was disease progression at that site
- No pre-existing ascites or pleural effusions
- No known CNS involvement by NHL
Prior/Concurrent Therapy:
Biologic therapy: - No prior allogeneic transplantation
- More than 30 days since prior hematopoietic growth factors
(e.g., filgrastim (G-CSF) or epoetin alfa)
- More than 30 days since prior immunotherapy
- More than 90 days since prior monoclonal antibodies as
monotherapy for patients who were unresponsive to treatment (30 days for
patients who responded to treatment and subsequently relapsed)
- No other concurrent biological agents
- No concurrent hematopoietic growth factors (e.g., G-CSF or
epoetin alfa)
Chemotherapy: - More than 30 days since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy: - More than 30 days since prior systemic
corticosteroids
- No concurrent systemic corticosteroids
Radiotherapy: - See Disease Characteristics
- More than 30 days since prior radiotherapy
- No concurrent radiotherapy
Surgery: Other: - Recovered from prior therapy
- At least 6 months since prior coronary angioplasty
- More than 30 days since prior immunosuppressants
- More than 30 days since prior participation in an
investigational drug study
- No concurrent immunosuppressants
- No concurrent anticoagulants except aspirin at doses no
greater than 325 mg/day
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - Neutrophil count at least 1,000/mm3
- Platelet count at least 50,000/mm3
Hepatic: - Bilirubin less than 2 mg/dL
- Transaminase less than 2 times upper limit of normal
- No hepatitis B or C
Renal: - Creatinine less than 2 mg/dL
Cardiovascular: - No significant cardiovascular disease
- No New York Heart Association class III congestive heart
failure
- No myocardial infarction within the past 6 months
- No unstable angina
- No uncontrolled atrial or ventricular cardiac
arrhythmias
Pulmonary: - No concurrent significant pulmonary disease
Other: - HIV negative
- No acute infection requiring antibiotics
- No fever over 38.2 degrees C within the past 3 days
- No other malignancy within the past 5 years except basal cell
or noninvasive squamous cell skin cancer or carcinoma in situ of the
cervix
- No pre-existing autoimmune disease or antibody-mediated
disease, including:
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Multiple
sclerosis
- Sjogren's syndrome
- Autoimmune thrombocytopenia
- Controlled thyroid disease allowed
- Concurrent autoantibodies without clinical autoimmune disease
allowed
- No history of allergic reactions attributed to compounds of
similar composition to study drugs
- No other medical history, including laboratory results, that
would preclude study
- No suspected or confirmed poor compliance or mental
instability that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment A total of 6-48 patients (3-24 per treatment group) will be accrued for this
study. Outline This is a multicenter, dose-escalation study of CpG 7909. Patients are
sequentially assigned to 1 of 2 treatment groups. - Group A: Patients receive rituximab IV over 4-5 hours followed by CpG
7909 IV over 2 hours on day 1. Courses repeat weekly for 4 weeks.
- Group B: Patients receive rituximab as above followed by CpG 7909
subcutaneously on day 1. Courses repeat weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Patients are followed at 4 weeks. Published ResultsLeonard JP, Link BK, Emmanouilides C, et al.: Phase I trial of toll-like receptor 9 agonist PF-3512676 with and following rituximab in patients with recurrent indolent and aggressive non Hodgkin's lymphoma. Clin Cancer Res 13 (20): 6168-74, 2007.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Jonsson Comprehensive Cancer Center at UCLA | | | Christos Emmanouilides, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma | | Trial Start Date | | 2002-03-13 | | Registered in ClinicalTrials.gov | | NCT00040950 | | Date Submitted to PDQ | | 2002-05-09 | | Information Last Verified | | 2003-07-30 | | NCI Grant/Contract Number | | P30-CA16042 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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