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CompletedNCT00487305Updated Aug 15, 2024

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma

A Phase 1 interventional study of Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells in Follicular Lymphoma, sponsored by Dana-Farber Cancer Institute. Completed at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Dana-Farber Cancer Institute · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
35 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the safety and immune activity of three doses of tumor vaccine. In recent years, researchers at the Dana-Farber Cancer Institute have discovered that vaccines made from patient's own cancer cell, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer. GM-CSF is a naturally occuring hormone in the body that helps our immune system fight infections and diseases. One of the goals of this study is to determine whether these vaccinations will improve the immune system's ability to recognize and destroy the participant's lymphoma cells.

Read the detailed description
  • The dose of vaccine will depend upon how many of the participant's own tumor cells are available and at which point they join study. This Phase I trial is a "dose escalation" study. This means that participants will be enrolled in groups. Group 2 will receive a larger dose than Group 1. Group 3 will receive a larger dose than Group 2.
  • The vaccine is administered in injections under and into the skin six times. Participants will receive vaccination shots once weekly for 3 vaccines, then every other week for 3 vaccines.
  • After the first and fifth vaccinations, a small amount of the participants own lymphoma cells (killed) will be injected under the skin to see if their immune system will react against it and cause redness and swelling. A punch skin biopsy will also be performed at these injection locations.
  • During the course of the study, we will also be drawing blood to evaluate immune cells and the effect that the vaccinations have on the participants immune system. During all treatment cycles a physical exam and questions about the participants general health will be performed.
  • After the final treatment (approximately week 10) the participant will undergo "re-staging" to assess the status of their disease. If after completion of six vaccines, evaluation of the participant's disease reveals that it is stable or responding to the vaccine, and there is still vaccine available, they may be eligible to continue to receive the vaccines every two weeks until their supply runs out.
  • After completion of the vaccinations, participants will come back for physical exams and blood tests every 3 months for 1 year and then once a year for fifteen years to monitor the effects of the vaccine.
02

Conditions studied

  • Follicular Lymphoma

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Keywords

  • GM-CSF
  • vaccine
  • K562
03

In context

Lymphoma, Follicular

964 studies on the registry are indexed under Lymphoma, Follicular; 242 are open to participants now.

This study's enrollment of 24 is below the median of 46 across 817 interventional studies indexed under Lymphoma, Follicular.

Browse Lymphoma, Follicular studies →

Lead sponsor

Dana-Farber Cancer Institute is the lead sponsor of 832 studies on the registry; 122 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically confirmed follicular lymphoma
  • Patients with relapsed follicular lymphoma achieving at least a PR following their most recent systemic chemotherapy and/or immunotherapy regimen.
  • Lymphoma accessible for sampling or existing cryopreserved lymphoma tumor judged suitable for vaccine preparation.
  • 4 weeks must have elapsed between the completion of the the last chemotherapy, immunotherapy, glucocorticoid therapy, radiotherapy, or experimental therapy.
  • ECOG Performance Status 0 or 1
  • Estimated life expectancy of > 6 months
  • 35 years of age or older
  • Adequate recovery of drug related toxicities, surgery or radiation therapy
  • Greater than 6 months since autologous stem cell transplantation
  • Laboratory parameters as outlined in the protocol

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled active infection or illness
  • Psychiatric illness/social situation that would limit study compliance
  • Pregnancy or nursing mothers
  • Evidence of infection with HIV or viral hepatitis
  • Other invasive malignancy
  • Existing autoimmune cytopenia
  • Previous allogeneic stem cell transplant
  • Pre-existing autoimmune disease requiring anti-inflammatory therapy
  • Participation in previous vaccine trial
  • Any component of grade 3 follicular lymphoma or transformed follicular lymphoma
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Biological/Vaccine

    Biological/Vaccine: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines. \--------------------------------------------------------------------------------

    Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells

Interventions

  • BiologicalLethally Irradiated Lymphoma cells with GM-CSF K562 Cells

    Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines.

06

What researchers measure

Primary outcomes

  1. To determine the safety and toxicity of administering vaccine composed of lethally irradiated lymphoma cells admixed with GM-CSF secreting K562 cells in patients with follicular lymphoma.

    Time frame: 2 years

Secondary outcomes

  1. To describe the biologic activity of the study vaccine

    Time frame: 2 years

  2. to determine tumor overall response rate as well as complete and partial response rates

    Time frame: 2 years

  3. to determine progression free survival and overall survival.

    Time frame: 2 years

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
08

References and documents

Publications

  • Jacobsen E, Plant A, Redd R, Armand P, McDonough M, Ihuoma U, Fisher DC, LaCasce A, Ritz J, Dranoff G, Freedman A. A phase I trial of vaccination with lethally irradiated lymphoma cells admixed with granulocyte-macrophage colony-stimulating factor secreting K562 cells for the treatment of follicular lymphoma. Leuk Lymphoma. 2024 Dec;65(12):1864-1874. doi: 10.1080/10428194.2024.2381651. Epub 2024 Jul 21. PubMed 39034493 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00487305
Responsible party
Eric Jacobsen, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Jun 18, 2007
Start date
Jun 2007
Primary completion
Jul 25, 2023
Completion
Jul 25, 2023
Last update
Aug 15, 2024

Study contacts

Eric Jacobsen, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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