Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.

Mycosis Fungoides Clinical Trial

Official title:

Phase I/II Study of Intratumoral Injection of CPG 7909, A TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00226993
• Other study ID #: LYMNHL0021
• Secondary ID: 95850LYMNHL0021
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: November 29, 2016
• Start date: March 2005

Study information

• Verified date: November 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• CPG 7909

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of intratumoral CpG injections combined with local radiation			Yes
Secondary	To determine local and systemic anti-tumor effect.			No
Secondary	To evaluate tumor-specific humoral and cellular immune responses			No