search
Back to results

Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma

Primary Purpose

Lymphoma, B-Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Adenovirus Interferon gamma
Sponsored by
Transgene
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Primary CBCL including (WHO/EORTC classification 2005), Primary cutaneous marginal zone B-cell lymphoma, Primary cutaneous follicle center B-cell lymphoma, Primary cutaneous diffuse large B-cell other than leg type, Histologically consistent with primary CBCL, Relapse or active disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must satisfy all the following criteria for entry into the protocol:

Primary CBCL including (according to WHO/EORTC classification 2005) :

  • Primary cutaneous marginal zone B-cell lymphoma
  • Primary cutaneous follicle center B-cell lymphoma

  • Primary cutaneous diffuse large B-cell other than leg type

    • Histologically consistent with primary CBCL.
    • Relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab).
    • Performance status of 0, 1 on the Eastern Cooperative Oncology Group (ECOG) scale (See Appendix E).
    • Minimum Life Expectancy > 3 months.
    • Adequate blood count: hemoglobin >= 10.0 g/dL; White Blood Count (WBC) >= 3.0 x 109/L; and platelet count >= 75 x 109/L.
    • Adequate hepatic function: bilirubin =< 1.5 times the upper limit of normal and serum transaminase (SGOT and SGPT)=< 2.5 times the upper limit of normal.
    • Adequate renal function: creatinine =< 1.5 times the upper limit of normal.
    • Written informed consent from patient.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

  • Primary cutaneous diffuse large B-cell lymphoma, leg type.
  • Primary cutaneous intravascular large B-cell lymphoma.
  • Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
  • No histologic documentation of CBCL.
  • History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
  • Serious uncontrolled, concomitant medical disorders.
  • Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
  • Major surgery in previous 4 weeks preceding the 1st injection.
  • Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
  • Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
  • Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
  • Patient previously included in this study.
  • Non compliance with the study.

Sites / Locations

  • Stanford University School of Medicine
  • Northwestern University Medical School
  • M.D. Anderson Cancer Center
  • Hopital Lapeyronie
  • Hopital de l'Hotel-Dieu
  • University Hospital of Zurich

Outcomes

Primary Outcome Measures

Regression and disappearance of lesions
Safety

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
October 31, 2006
Last Updated
July 15, 2014
Sponsor
Transgene
search

1. Study Identification

Unique Protocol Identification Number
NCT00394693
Brief Title
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
Official Title
Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transgene

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL. Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
Primary CBCL including (WHO/EORTC classification 2005), Primary cutaneous marginal zone B-cell lymphoma, Primary cutaneous follicle center B-cell lymphoma, Primary cutaneous diffuse large B-cell other than leg type, Histologically consistent with primary CBCL, Relapse or active disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
Adenovirus Interferon gamma
Intervention Description
intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
Primary Outcome Measure Information:
Title
Regression and disappearance of lesions
Time Frame
end of cycle
Title
Safety
Time Frame
visit
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must satisfy all the following criteria for entry into the protocol: Primary CBCL including (according to WHO/EORTC classification 2005) : Primary cutaneous marginal zone B-cell lymphoma Primary cutaneous follicle center B-cell lymphoma Primary cutaneous diffuse large B-cell other than leg type Histologically consistent with primary CBCL. Relapse or active disease after radiotherapy or other adequate therapy if radiotherapy was contra-indicated (chemotherapy, surgical excision, interferonα, rituximab). Performance status of 0, 1 on the Eastern Cooperative Oncology Group (ECOG) scale (See Appendix E). Minimum Life Expectancy > 3 months. Adequate blood count: hemoglobin >= 10.0 g/dL; White Blood Count (WBC) >= 3.0 x 109/L; and platelet count >= 75 x 109/L. Adequate hepatic function: bilirubin =< 1.5 times the upper limit of normal and serum transaminase (SGOT and SGPT)=< 2.5 times the upper limit of normal. Adequate renal function: creatinine =< 1.5 times the upper limit of normal. Written informed consent from patient. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: Primary cutaneous diffuse large B-cell lymphoma, leg type. Primary cutaneous intravascular large B-cell lymphoma. Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy). No histologic documentation of CBCL. History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections. Serious uncontrolled, concomitant medical disorders. Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing) Major surgery in previous 4 weeks preceding the 1st injection. Pregnancy at study entry or who become pregnant during the study or women who are breast feeding. Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection. Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection. Patient previously included in this study. Non compliance with the study.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5334
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hopital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital de l'Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8090
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24586226
Citation
Dreno B, Urosevic-Maiwald M, Kim Y, Guitart J, Duvic M, Dereure O, Khammari A, Knol AC, Derbij A, Lusky M, Didillon I, Santoni AM, Acres B, Bataille V, Chenard MP, Bleuzen P, Limacher JM, Dummer R. TG1042 (Adenovirus-interferon-gamma) in primary cutaneous B-cell lymphomas: a phase II clinical trial. PLoS One. 2014 Feb 24;9(2):e83670. doi: 10.1371/journal.pone.0083670. eCollection 2014.
Results Reference
derived
PubMed Identifier
24063735
Citation
Accart N, Urosevic-Maiwald M, Dummer R, Bataille V, Kehrer N, Niculescu C, Limacher JM, Chenard MP, Bonnefoy JY, Rooke R. Lymphocytic infiltration in the cutaneous lymphoma microenvironment after injection of TG1042. J Transl Med. 2013 Sep 25;11:226. doi: 10.1186/1479-5876-11-226.
Results Reference
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/lymphoma.html
Description
Related Info

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma

We'll reach out to this number within 24 hrs