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LymphomaPhase 1NCT00561756

Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma

A Phase 1 study testing plasmid DNA vaccine therapy, flow cytometry and immunoenzyme technique in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

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

RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
plasmid DNA vaccine therapy, flow cytometry and immunoenzyme technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Oct 2007to Nov 2015
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a functional immune system as determined by the following tests:
  • Serum proteins immunoelectrophoresis (serum IgG levels ≥ 0.5 g/dL are required)
  • No evidence of anergy as shown by positive skin test with tetanus toxoid, mumps or Candida. OR
  • Circulating T-cells as measured by flow cytometry (serum CD4+ and CD8+ T-cell counts ≥ 250 and 150 cells/μL, respectively) Patients must have histologically proven (and confirmed at MSKCC) B-cell lymphoma of any histology, excluding Burkitt's lymphoma, Lymphoblastic lymphoma (due to their aggressiveness and low likelihood of response to immune therapy).
  • CD20 surface expression must be confirmed by immunohistochemical staining or flow.
  • Measurable disease is not a pre-requisite for enrollment in the study. However, if a patient does have measurable disease as evidenced by imaging studies, these have to be done within eight weeks of starting treatment.
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  • Patients must have a Karnofsky performance status ≥ 70%.
  • Patients with evidence of active disease, progression of disease or relapsed disease following one or more prior regimens of chemotherapy, immunotherapy or radiation therapy (including autologous stem cell transplants), not requiring immediate cytoreductive chemotherapy. All treatment must be completed at least four weeks prior to administration of the first vaccination, except immunotherapy and radioimmunotherapy, which must be completed at least 90 days prior to receiving the first vaccination. Active disease includes patients with minor or partial responses after therapy as evidenced by FDG-avid disease or biopsy.
  • Age ≥ 18.
  • Adequate contraception during study enrollment.
  • Avoidance of breast-feeding their infants during the study enrollment.
  • Patients must have adequate organ and marrow function as defined below:
  • Absolute Neutrophil Count ≥ 1,000/uL
  • Platelets ≥ 75,000/uL
  • Total bilirubin ≤ 2.5 times institutional upper limit
  • AST/ALT ≤ 2.5 times institutional upper limit
  • Creatinine ≤ 2 mg/dL
  • PT/PTT ≤ 1.5 times institutional upper limit
  • Patients must have no signs of congestive heart failure according to the New York Heart Failure Guidelines Class III/IV.

Who cannot join

  • Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study.
  • Patients who have undergone an allogeneic stem cell transplant at any time.
  • Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients who have received immunotherapy (i.e. rituximab) or radioimmuno therapy (i.e. tositumomab or ibritumomab) within the past 90 days.
  • Patients who display signs of anergy as indicated by skin testing.
  • Patients with Burkitt's lymphoma and Lymphoblastic Lymphoma.
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  • Patients who have been previously immunized with any type of DNA vaccine.
  • Patients who have positive anti-DS-DNA antibodies.
  • Patients with life expectancy less than 3 months from the time of enrollment.
  • Patients with serious underlying medical conditions, active infections requiring the use of antimicrobial drugs or active bleeding.
  • Patients with active Hepatitis C (HC) or Hepatitis B (HB) infection, the latter defined as a positive test for HBsAg or measurable viral load. In patients who are HBsAg negative but HBsAg positive (regardless of HBsAb status), a HB viral load will be performed and if positive the subject will be excluded. If the subject is HBsAg negative, HBcAb positive (regardless of HBsAb status) but with negative HBV viral load, the subject may be included but must undergo HBV DNA PCR testing at least every two months from the start of treatment during the routine study visits for as long as the subject remains on study. Prophylactic antiviral therapy, in addition to the monitoring described above, may be initiated at the discretion of the investigator.
  • Patients with documented HIV infection or other immunodeficiency disorder or on chronic steroids treatment.
  • Patients with autoimmune diseases such as but not limited to rheumatoid arthritis, Sjogren disease, ulcerative colitis, autoimmune hepatitis.
  • Pregnant or nursing women. Women of child-bearing age will be tested for qualitative β-HCG within 2 weeks of immunization.
  • Patients receiving other investigational drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase I Trial to Assess Safety and Immunogenicity of Xenogeneic CD20 DNA Vaccination With Patients With B-Cell Lymphoma

RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the safety and feasibility of intramuscular DNA vaccination with a plasmid DNA vector expressing the mouse extracellular domain of CD20, namely pINGmminiCD20. Doses of pING-mminiCD20 will be escalated by group to determine the optimal biological dose.

Secondary

  • To evaluate antibody and T-cell responses to CD20 after vaccination.
  • To observe patients for evidence of any antitumor response generated after vaccination.

OUTLINE: The entire immunization schedule comprises five injections administered every three weeks (for a total of approximately four and one half months). After the second injection, blood will be drawn for assessment of antibody and T-cell responses. After the fifth and final injection, blood will again be drawn for assessment of antibody and T-cell responses.

Conditions
Lymphoma
Being tested
plasmid DNA vaccine therapy, flow cytometry, immunoenzyme technique
Keywords
cutaneous B-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, recurrent marginal zone lymphoma, recurrent mantle cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

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

  • plasmid DNA vaccine therapyBiological

  • flow cytometryOther

  • immunoenzyme techniqueOther

Study groups in NCT00561756
Study groupRoleWhat they receive
Vaccine TherapyExperimentalThis single arm, open-label, phase I clinical trial of xenogeneic CD20 DNA vaccination is designed to evaluate its safety in patients with B cell lymphoma. The study is a dose escalation study at three test doses, 0.5 mg, 2 mg and 4 mg of purified plasmid DNA per injection. There will be an initial cohort of three patients receiving a pre-level 1 dose of 0.1 mg/vaccination before proceeding to the three test doses.
Receives: Biological: plasmid DNA vaccine therapy; Other: flow cytometry; Other: immunoenzyme technique

What is being measured

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

  1. Safety and immunogenicity

    Measured: 2 years

Secondary outcomes (2)

  1. Antibody and T-cell responses against CD20

    Measured: 2 years

  2. Antitumor response

    Measured: 2 years

Timeline

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

  1. First posted21 Nov 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionNov 2015
  4. Study completionNov 2015

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561756
Sponsor's protocol ID
07-100
Other IDs
MSKCC-07100
Status last verified
Nov 2015
First submitted
20 Nov 2007
Last updated
17 Nov 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing plasmid DNA vaccine therapy, flow cytometry and immunoenzyme technique in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

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 19 inclusion and 15 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 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety and immunogenicity (time frame: 2 years). 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 NCT00561756.

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 17 Nov 2015.

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