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Phase I/II Randomized Study of CpG 7909 in Patients With Stage IB-IVA Cutaneous T-Cell Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
CpG 7909 in Treating Patients With Cutaneous T-Cell Lymphoma
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase II, Phase I | Treatment | Closed | 18 and over | UCLA-030104201A CPGI-C014, CPGI-CPG7909-C014, NCT00091208 |
Objectives Primary - Determine the safety of CpG 7909, in terms of adverse events, vital signs, and laboratory and clinical findings, in patients with stage IB-IVA cutaneous T-cell lymphoma.
- Determine tumor response, as measured by the Composite Assessment of Index Lesion Disease Severity (CA), in patients treated with this drug.
- Determine the tolerability of this drug in these patients.
- Determine the immunopharmacodynamics of this drug in these patients.
Secondary - Determine disease response, based on the Physician Global Assessment of Clinical Condition (PGA), in patients treated with this drug.
- Determine duration of response, based on the CA and PGA, in patients treated with this drug.
- Determine time to response in patients treated with this drug.
- Determine time to progression in patients treated with this drug.
Entry Criteria Disease Characteristics:
- Histologically confirmed cutaneous T-cell lymphoma (CTCL) (limited to mycosis fungoides)
- Stage IB-IVA disease
- No other cutaneous lymphomas including, but not limited to, CD30-positive large-cell T-cell lymphoma, lymphomatoid papulosis, and pagetoid reticulosis
- No visceral disease (stage IVB CTCL)
- Must have received 1-3 prior systemic regimen(s), including psoralen ultraviolet light therapy (PUVA)
- No CNS disease
Prior/Concurrent Therapy:
Biologic therapy - No concurrent denileukin diftitox
- No other concurrent immunotherapy, including but not limited to, interleukin-2, interferon (IFN) alfa, or IFN gamma
Chemotherapy - At least 4 weeks since prior systemic chemotherapy for CTCL
- No concurrent chemotherapy
Endocrine therapy - No concurrent topical or systemic corticosteroids
Radiotherapy - At least 4 weeks since prior electron beam therapy for CTCL
- No concurrent radiotherapy
Surgery - More than 6 months since prior coronary angioplasty
Other - At least 2 weeks since prior topical therapy for CTCL
- At least 3 weeks since prior phototherapy for CTCL
- At least 4 weeks since prior photopheresis for CTCL
- At least 4 weeks since other prior systemic therapy for CTCL
- At least 4 weeks since prior daily systemic cholecalciferol (vitamin D) > 15,000 IU for CTCL
- At least 4 weeks since prior oral retinoids, including bexarotene for CTCL
- At least 4 weeks since prior investigational therapy for CTCL
- No prior treatment for hepatitis B or C
- More than 2 weeks since prior systemic antibiotics for CTCL
- Patients receiving systemic antibiotics for CTCL must be on a stable regimen for at least 2 weeks before study entry
- More than 30 days since prior participation in an investigational drug trial
- No concurrent chloroquine phosphatase
- No concurrent anticoagulant therapy except aspirin (≤ 325 mg/day)
- No concurrent phototherapy
- No concurrent photopheresis therapy
- No concurrent bexarotene
- No concurrent immunosuppressants
- No other concurrent investigational drugs
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Neutrophil count ≥ 1,000/mm3
- Platelet count > 100,000/mm3
- WBC > 4,000/mm3
- Hemoglobin ≥ 10 g/dL
Hepatic - Bilirubin ≤ 1.5 mg/dL
- SGOT or SGPT < 3 times upper limit of normal
- PTT ≤ 40 seconds
- No active hepatitis B or C
Renal Cardiovascular - No unstable angina
- No New York Heart Association class III-IV congestive heart failure
- No myocardial infarction within the past 6 months
- No uncontrolled atrial or ventricular cardiac arrhythmias
- No other significant cardiovascular disease
Immunologic - HIV negative
- No autoimmune or antibody-mediated disease, including any of the following:
- Systemic lupus erythematosus
- Rheumatoid arthritis
- Multiple sclerosis
- Sjögren's syndrome
- Autoimmune thrombocytopenia
- Controlled thyroid disease allowed
- Autoantibodies without clinical autoimmune disease allowed
- No history of allergic reactions attributed to compounds of similar composition to CpG 7909
- No fever ≥ 38.2°C within the past 24 hours
- No serious, symptomatic, significant local or systemic infection, including urinary tract infection
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse that would preclude study participation or giving informed consent
- No other medical history, including laboratory results, that would preclude study participation
- No other malignancy within the past 5 years except basal cell or completely excised non-invasive squamous cell skin cancer or squamous cell carcinoma in situ of the cervix
Expected Enrollment A total of 3-56 patients (3-36 for phase I and 20 [10 per treatment arm] for phase II) will be accrued for this study. Outcomes Primary Outcome(s)Tumor response rate (complete clinical response [CCR] and partial response [PR]) as measured by the Composite Assessment of Index Lesion Disease Severity
Secondary Outcome(s)Tumor response as measured by the Physician Global Assessment of Clinical Condition criteria Duration of overall response (CCR and PR) Duration of CCR Duration of PR Time to response Time to disease progression
Outline This is a phase I, open-label, multicenter, dose-escalation study followed by a randomized phase II study. Patients are followed every 4 weeks.
Trial Contact Information
Trial Lead Organizations Jonsson Comprehensive Cancer Center at UCLA | | | Lauren Pinter-Brown, MD, Protocol chair | | | |
Registry Information | | Official Title | | A Phase I/II Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage IB To IVA Cutaneous T-Cell Lymphoma | | Trial Start Date | | 2004-07-30 | | Registered in ClinicalTrials.gov | | NCT00091208 | | Date Submitted to PDQ | | 2004-07-30 | | Information Last Verified | | 2006-04-11 | | NCI Grant/Contract Number | | 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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