NCT00226993

Brief 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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

November 29, 2016

Conditions

Mycosis Fungoides

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of intratumoral CpG injections combined with local radiation

Secondary Outcomes (2)

  • To determine local and systemic anti-tumor effect.

  • To evaluate tumor-specific humoral and cellular immune responses

Interventions

CPG 7909DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kim YH, Gratzinger D, Harrison C, Brody JD, Czerwinski DK, Ai WZ, Morales A, Abdulla F, Xing L, Navi D, Tibshirani RJ, Advani RH, Lingala B, Shah S, Hoppe RT, Levy R. In situ vaccination against mycosis fungoides by intratumoral injection of a TLR9 agonist combined with radiation: a phase 1/2 study. Blood. 2012 Jan 12;119(2):355-63. doi: 10.1182/blood-2011-05-355222. Epub 2011 Nov 1.

    PMID: 22045986DERIVED

MeSH Terms

Conditions

Mycosis Fungoides

Interventions

ProMune

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, CutaneousLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ronald Levy

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert K. and Helen K. Summy Professor in the School of Medicine

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 27, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2006

Last Updated

December 1, 2016

Record last verified: 2016-11