Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma

NCT00561756 | Completed Phase 1

• 2 other identifiers: 07-100MSKCC-07100
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

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

Outcome Measures

Primary Outcomes (1)

• Safety and immunogenicity

  2 years

Secondary Outcomes (2)

• Antibody and T-cell responses against CD20

  2 years

• Antitumor response

  2 years

Study Arms (1)

Vaccine Therapy

EXPERIMENTAL

This 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.

Biological: plasmid DNA vaccine therapy; Other: flow cytometry; Other: immunoenzyme technique

Interventions

plasmid DNA vaccine therapy BIOLOGICAL

Vaccine Therapy

flow cytometry OTHER

Vaccine Therapy

immunoenzyme technique OTHER

Vaccine Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Interventions

Flow Cytometry; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• M. Lia Palomba, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Andrew D. Zelenetz, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Alan N. Houghton, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)