- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226993
Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.
November 29, 2016 updated by: Ronald Levy, Stanford University
Phase I/II Study of Intratumoral Injection of CPG 7909, A TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides
This is a single institution phase I / II trial to evaluate the safety and efficacy of intratumoral CpG injections combined with local radiation in patients with mycosis fungoides.
Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day).
CpG injections will be administered into the same tumor site within 24 hours before or 24 hours after each radiation treatment.
Weekly doses of (intratumoral or peritumoral injections) CpG will be then administered subcutaneously in the region of previous injections for 23 additional doses.
The total treatment duration is 24 weeks.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:- Biopsy confirmed mycosis fungoides of stage IB-IVA. Patients must have failed or have been intolerant of at least 2 topical or one systemic treatment.
- Patients must have at least one site of disease that is accessible for intratumoral injection of CpG percutaneously, and the second site to follow treatment response.
- 18 years of age or older
- Karnofsky Performance Status (KPS) of > 70.
- Adequate bone marrow function: WBC>4,000uL, hemoglobin > 10g/dL; platelet count >100,000/mm^3; ANC> 1000.
- Adequate hepatic function: bilirubin <= 1.5 mg/dL; SGOT/SGPT<3xupper limit of normal
- Adequate renal function: serum creatinine <= 2.0mg/dL.
Required wash out periods for prior therapy:
- Topical therapy: 2 weeks
- Chemotherapy: 4 weeks
- Radiotherapy (including photo therapy): 4 weeks
- Systemic biological therapy for mycosis fungoides: 4 weeks
- Other investigational therapy: 4weeks
- Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration.
- Women of reproductive potential must have negative urine pregnancy test.
- Life expectancy greater than 4 months.
- Able to comply with the treatment schedule. Exclusion Criteria:- Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
- Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both).
- Patients with active infection or with a fever >38.50 C within three days prior to the first scheduled treatment.
- CNS metastases
- Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.
- Prior treatment with CpG.
- History of allergic reactions attributed to compounds of similar composition to CPG 7909
- Current anticoagulant therapy (ASA<= 325mg/day allowed).
- Significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- Pregnant or lactating.
- Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety and efficacy of intratumoral CpG injections combined with local radiation
|
Secondary Outcome Measures
Outcome Measure |
---|
To determine local and systemic anti-tumor effect.
|
To evaluate tumor-specific humoral and cellular immune responses
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Anticipated)
December 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimate)
September 27, 2005
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 29, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYMNHL0021
- 95850
- NCT00226993
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mycosis Fungoides
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Mycosis Fungoides | Refractory Mycosis Fungoides | Stage I Mycosis Fungoides | Stage II Mycosis Fungoides | Stage III Mycosis FungoidesUnited States
-
National Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8 | Recurrent Mycosis Fungoides... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingSezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Transformed Mycosis Fungoides | Folliculotropic... and other conditionsUnited States
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Northwestern UniversityAmgenTerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...WithdrawnRecurrent Mycosis Fungoides and Sezary Syndrome | Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IIB Mycosis Fungoides and Sezary Syndrome | Stage IIIA Mycosis Fungoides and Sezary Syndrome | Stage IIIB Mycosis Fungoides and Sezary Syndrome | Stage IVA Mycosis Fungoides and Sezary Syndrome | Stage...
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Rochester Skin Lymphoma Medical Group, PLLCRochester General HospitalCompletedMycosis Fungoides | Cutaneous T-cell Lymphoma | Transformed Mycosis Fungoides | Cutaneous T-cell Lymphoma Stage I | Folliculotropic Mycosis Fungoides | Granulomatous Slack Skin | Syringotropic Mycosis Fungoides | Mycosis Fungoides VariantUnited States
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Memorial Sloan Kettering Cancer CenterRecruitingMycosis Fungoides | Sezary Syndrome | Mycosis Fungoides/Sezary Syndrome | Sézary | Advanced Mycosis FungoidesUnited States
Clinical Trials on CPG 7909
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PfizerCompleted
-
University of IowaNational Cancer Institute (NCI); Mayo Clinic; PfizerCompletedChronic Lymphocytic LeukemiaUnited States
-
Ronald LevyAmerican Society of Clinical Oncology; Lymphoma Research FoundationCompletedMycosis Fungoides | Non-Hodgkin LymphomaUnited States
-
Ludwig Institute for Cancer ResearchCompletedProstate CancerSwitzerland, Germany
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Ronald LevyPfizerCompletedLymphoma | Lymphoma, Non-Hodgkin | Lymphomas: Non-Hodgkin | Lymphomas: Non-Hodgkin Follicular / Indolent B-CellUnited States
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PfizerCompletedMelanoma | Carcinoma, Renal Cell | Breast Neoplasms | Carcinoma, Non-Small-Cell Lung | Lymphoma, T-CellUnited States, Germany
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National Institute of Allergy and Infectious Diseases...Terminated
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University of AarhusAarhus University HospitalCompleted