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Home > "P" Clinical Trials Conditions > Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma  Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
For Condition: Lymphoma, T-Cell, Cutaneous
Status: Recruiting
Sponsor(s): Coley Pharmaceutical Group ,
Synopsis: Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments. Exclusion:Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded. Patients who have received treatment with Denileukin diftitox will be excluded. Women who are pregnant, lactating or unable/unwilling to use contraception will be excluded. In the phase I portion of the protocol, patients will be included in escalating dose groups of CpG 7909. Patients will be treated once weekly, SC, for 24 weeks. In the Phase II portion of the trial, patients will be treated at the MTD identified in the initial Phase I dose escalation portion of the trial. All patients in Phase I and Phase II will be treated for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION: - Biopsy confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF) Stage IB–Stage IVA inclusive; clinical staging confirmed at screening (refer to Appendix D). Other cutaneous lymphomas including, but not limited to, CD30+ large celled T-cell lymphoma, lymphomatoid papulosis, and pagetoid reticulosis, are excluded). Patients must have received at least one and no more than 3 prior systemic therapies (may include bexarotene), excluding Denileukin diftitox. - Karnofsky Performance Status >/= 60 - > 18 years of age - Adequate bone marrow reserve: WBC > 4,000 μL; hemoglobin >/=10 g/dL; platelet count > 100,000 mm3; neutrophils > 1000/ μL - Adequate renal function: serum creatinine 15,000 IU daily, oral retinoids (including bexarotene), or investigational therapy; 4 weeks – chemotherapy - Patients of reproductive potential and their partners must agree to use an effective (> 90% reliability) form of birth control during the study and for 4 weeks following the last study drug administration. - Women of reproductive potential: negative pregnancy test (urine and/or serum β-hCG) - Life expectancy of greater than 4 months - Signed Informed Consent Form - Able to comply with the treatment schedule EXCLUSION: - Pre-existing autoimmune or antibody-mediated diseases 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 - Serious infection or illness including human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both) - History of pancreatitis - Use of systemic antibiotics for CTCL within 2 weeks or be on a stable regimen for ³ 2 weeks before study entry - Prior malignancy except basal cell or non-invasive squamous cell carcinoma of the skin or in situ squamous cell carcinoma of the cervix - History of allergic reactions attributed to compounds of similar composition to CpG 7909 - Current anticoagulant therapy (exception, ASA < 325 mg/day allowed) - Significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias) - Prior Denileukin diftitox therapy - Visceral disease involvement (Stage IVB cutaneous T-cell lymphoma) including CNS involvement - Participation in an investigational drug trial within 30 days prior to screening - Suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse deemed by the Investigator to be likely to effect their ability to sign the informed consent, or undergo study procedures - Presentation with, or a recent history (within 24 hours) of a fever > 38.2°C or symptoms of significant local infection or systemic infection, including urinary tract infections – such patients will be deferred from enrollment at least until 48 hours after illness has resolved - 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
Total Enrollment: 52
Location and Contact Information:
MD Anderson *Recruiting*
Houston, Texas, 77030
United States
Recruiting Madeline Duvic 713-745-1113
Additional Information:
Study ID Numbers: C014;
Study Start Date: August 2002
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043420
Other Lymphoma, T-Cell, Cutaneous Studies:
1. Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
2. A Safety/Efficacy Study of SGN-30 (Antibody) in Patients with Refractory or Recurrent CD30+ Hematologic Malignancies
3. Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) with Yttrium-90 Radiolabeled Anti-Tac
4. Open label study of ONTAK (denileukin diftitox) in previously treated Cutaneous T-cell Lymphoma patients.
5. Randomized double-blind study of ONTAK (denileukin diftitox) in cutaneous T-cell lymphoma (CTCL) patients.
Related Studies:
Other Lymphoma, T-Cell, Cutaneous Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I/II Multi-Center, Open Label Study of CpG 7909 in Patients with Cutaneous T-Cell Lymphoma
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