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Lymphoma, B-CellPhase 2NCT00394693

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

A Phase 2 study testing Adenovirus Interferon gamma in people with Lymphoma, B-Cell, run by Transgene at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
Adenovirus Interferon gamma
Type of treatment
Injection or infusion
How many people
13 participants
Where
6 sitesin 3 countries
Study dates
Nov 2006to Apr 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States3 sites

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford University School of Medicine

    Stanford, California, 94305-5334

Other trials in United States

France2 sites

  • Hopital Lapeyronie

    Montpellier, 34295

  • Hopital de l'Hotel-Dieu

    Nantes, 44093

Other trials in France

Switzerland1 site

  • University Hospital of Zurich

    Zurich, 8090

Other trials in Switzerland

About this study

Official title: Phase II Clinical Trial of Intra-lesional Administration of TG1042 (Adenovirus-Interferon-gamma) in Patients With Relapsing Primary Cutaneous B-Cell Lymphomas.

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.

Being tested
Adenovirus Interferon gamma
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
Medical subject headings
Lymphoma, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adenovirus Interferon gammaGenetic

    intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regression and disappearance of lesions

    Measured: end of cycle

  2. Safety

    Measured: visit

Secondary outcomes (1)

  1. Quality of Life

    Measured: visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00394693
Sponsor's protocol ID
TG1042.06
Status last verified
Jul 2014
First submitted
31 Oct 2006
Last updated
16 Jul 2014
Results posted
No

Publications

  • 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.

    PubMed 24586226

  • 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.

    PubMed 24063735

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adenovirus Interferon gamma in people with Lymphoma, B-Cell, run by Transgene at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regression and disappearance of lesions (time frame: end of cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00394693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.

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