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LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's Lymphoma"


N/A
18 Years
90 Years
Open (Enrolling)
Both
Cutaneous B-cell Non-Hodgkin Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Adult Diffuse Mixed Cell Lymphoma, Adult Diffuse Small Cleaved Cell Lymphoma, Adult Grade III Lymphomatoid Granulomatosis, Adult Immunoblastic Large Cell Lymphoma, Adult Lymphoblastic Lymphoma, Grade 1 Follicular Lymphoma, Grade 2 Follicular Lymphoma, Grade 3 Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia With Nodal Disease

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Trial Information

LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for Patients With B-Cell Non-Hodgkin's Lymphoma"


PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence
of significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site
(Arm A). II. Evaluation of safety and tolerability as measured by the incidence of
significant toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro
and delivered intradermally (ID) (Arm B). SECONDARY OBJECTIVES: I. For cryoablation
candidates: To assess feasibility, overall response rate, clinical benefit rate, time to
response, and duration of response (Arm A). II. For patients receiving ID vaccine without
cryoablation: To assess feasibility, clinical response rate, time to response, and duration
of response (Arm B). TERTIARY OBJECTIVES: I. For cryoablation candidates: To assess the
change over time in non-cryoablated nodes selected as the index lesions (Arm A). II. For
patients receiving ID vaccine without cryoablation: To assess the change over time in
measurable nodes selected as the index lesions (Arm B). III. To monitor patients' immune
response after vaccine therapy. IV. Assess the immune response to Prevnar in cancer
patients. V. Assess the effect of DC vaccination on presence of myeloid suppressors. VI.
Assess the effect of tumor antigen delivery methods (in vivo DC into cryoablated tumor vs.
ID injection of in vitro generated DC + lysate) on T cell response. OUTLINE: Patients are
assigned to 1 of 2 treatment arms. In both arms, treatment continues in the absence of
disease progression or unacceptable toxicity. After completion of study treatment, patients
are followed up every 3 months for 1 year, and then every 6 months for up to 2.5 years.


Inclusion Criteria:



- Histological confirmation of biopsy-proven B-cell non-Hodgkin's lymphoma, excluding
chronic lymphocytic leukemia, primary CNS lymphoma and Burkitt's lymphoma.

- Patient must have at least 2 measurable lesions that are >= 1.5cm in one dimension.
One of the lesions, must meet additional criteria a or b depending on the treatment
arm. a) For Arm A, patient must have at least one lesion that is >= 2.0cm and is
amenable to image-guided cryoablation and multiple vaccine injections as determined
by Interventional Radiology (including tumors that can be safely accessed using
imaging guidance and treated with minimal risk to adjacent structures). b) For Arm B,
patient must have one lesion that can be excised for in vitro vaccine preparation.

- ECOG Performance Status (PS) 0, 1, 2

- Absolute neutrophil count > 1000/uL

- Absolute lymphocyte count > 500/uL

- PLT >= 100,000/uL

- HgB >= 8.0 g/dL

- Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x
ULN, the direct bilirubin must be normal

- Negative serum pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Provide informed written consent

- Willingness to return to a Lymphoma SPORE enrolling institution for follow-up

- Patient willing to provide tissue and blood samples for research purposes

Exclusion Criteria:

- Pregnant women

- Nursing women

- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Patients known to be HIV positive

- Serious non-malignant disease such as active infection, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations or other conditions which in the opinion of the investigator would
compromise protocol objectives

- Receiving any other investigational agent considered as a treatment for the primary
neoplasm

- History of other primary malignancy requiring systemic treatment within 6 months of
protocol enrollment

- Patients must not have another active malignancy requiring treatment

- Patients must not be receiving chemotherapy or immunotherapy for another cancer

- Prior allogeneic bone marrow or peripheral blood stem cell transplantation

- Prior autologous bone marrow or peripheral blood stem cell support within 1 year

- Major surgery other than diagnostic surgery =< 4 weeks

- History of hypersensitivity and anaphylactoid reactions to pneumococcal vaccine or
any component of the formulation, including diphtheria toxoid

- Active autoimmune disease such as Crohn's disease, rheumatoid arthritis, Sjogrens'
disease, systemic lupus erythematosis, or similar conditions

- Coagulopathy, including the use of Coumadin or heparin anticoagulants that cannot be
discontinued for the cryoablation procedure (NOTE: Heparin for line patency without
detectable lab abnormalities for coagulation will be allowed)

- Patients must be off corticosteroids for at least 2 weeks prior to registration (this
includes oral, IV, subcutaneous, or inhaled route of administration); patients on
chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they
receive less than 10 mg/day of prednisone (or equivalent)

- Patients with active CNS malignancy are not eligible for this trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE

Outcome Time Frame:

At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease

Safety Issue:

Yes

Principal Investigator

Yi Lin, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

LS1081

NCT ID:

NCT01239875

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Cutaneous B-cell Non-Hodgkin Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Adult Diffuse Mixed Cell Lymphoma
  • Adult Diffuse Small Cleaved Cell Lymphoma
  • Adult Grade III Lymphomatoid Granulomatosis
  • Adult Immunoblastic Large Cell Lymphoma
  • Adult Lymphoblastic Lymphoma
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3 Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia With Nodal Disease
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphomatoid Granulomatosis
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Mantle-Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905