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Cutaneous B-cell Non-Hodgkin LymphomaEarly Phase 1NCT01239875

Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma

A Early Phase 1 study testing dendritic cell vaccine therapy, cryotherapy and pneumococcal polyvalent vaccine in people with Cutaneous B-cell Non-Hodgkin Lymphoma and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by Mayo Clinic 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, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
dendritic cell vaccine therapy, cryotherapy and pneumococcal polyvalent vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Nov 2010to 17 Jul 2019
Phase
Early 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.

Read the detailed description

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.

Being tested
dendritic cell vaccine therapy, cryotherapy, pneumococcal polyvalent vaccine, laboratory biomarker analysis, immunoenzyme technique
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • dendritic cell vaccine therapyBiological

    Given intratumorally

  • cryotherapyProcedure or surgery

    Undergo cryoablation

  • pneumococcal polyvalent vaccineBiological

    Also called Pneumovax 23, Pnu-Imune 23

    Given intramuscularly

  • laboratory biomarker analysisOther

    Correlative studies

  • immunoenzyme techniqueOther

    Also called immunoenzyme techniques

    Correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • autologous dendritic cell-tumor fusion vaccineBiological

    Given intradermally

Study groups in NCT01239875
Study groupRoleWhat they receive
Arm AExperimentalPatients receive pneumococcal polyvalent vaccine intramuscularly in weeks -4, 2, and 10. Patients undergo cryoablation followed by dendritic cell vaccine (CA-DC) intratumorally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
Receives: Biological: dendritic cell vaccine therapy; Procedure: cryotherapy; Biological: pneumococcal polyvalent vaccine; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method
Arm BExperimentalPatients receive pneumococcal polyvalent vaccine as in arm A. Patients also receive autologous dendritic cell-tumor fusion vaccine (TL-DC) intradermally in weeks 0, 2, 4, 6, 10, 14, 18, and 22.
Receives: Biological: dendritic cell vaccine therapy; Biological: pneumococcal polyvalent vaccine; Other: laboratory biomarker analysis; Other: immunoenzyme technique; Other: immunohistochemistry staining method; Biological: autologous dendritic cell-tumor fusion vaccine

What is being measured

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

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

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

Secondary outcomes (8)

  1. Overall response rate

    Measured: At week 4 (arm A) or 2 (arm B) and then every 3 months for 1 year starting at week 10

  2. Feasibility as estimated by the number of patients receiving at least one dose of tumor antigen loading and vaccine delivery divided by the number receiving leukapheresis

    Measured: Up to 2.5 years

  3. Clinical benefit rate as estimated by the number of patients with an objective status of stable disease (SD) or an objective status of CR or PR

    Measured: For at least 12 months

  4. Time to response

    Measured: From the date of initiation of vaccination treatment to the date at which the patient's objective status is first noted to be either a CR or PR

  5. Duration of response

    Measured: From the date at which the patient's objective status is first noted to be either a CR or PR to the earliest date progression is documented

  6. Percent change from baseline in index lesion measurements as a marker of distant immune and treatment response

    Measured: At day 1 of courses 1-4 (arm A) and 1-6 (arm B)

  7. Change in immunologic correlates before and after vaccination treatment

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

  8. Correlation of immunologic markers with cancer and treatment-related outcomes (e.g., response, toxicities)

    Measured: Up to 2.5 years

Timeline

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

  1. First posted11 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completion24 Nov 2015
  4. Study completion17 Jul 2019

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
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01239875
Sponsor's protocol ID
LS1081
Other IDs
NCI-2010-02003, LS1081, 10-003023
Status last verified
Jan 2019
First submitted
27 Oct 2010
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing dendritic cell vaccine therapy, cryotherapy and pneumococcal polyvalent vaccine in people with Cutaneous B-cell Non-Hodgkin Lymphoma and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by Mayo Clinic 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 12 inclusion and 17 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 14 Jan 2020. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE (time frame: At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease). 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 NCT01239875.

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 14 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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