Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
August 13, 2024 updated by: Eric Jacobsen, MD, Dana-Farber Cancer Institute
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 Previously Untreated or Relapses Follicular Lymphoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. -------------------------------------------------------------------------------- |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To describe the biologic activity of the study vaccine
Time Frame: 2 years
|
2 years
|
|
to determine tumor overall response rate as well as complete and partial response rates
Time Frame: 2 years
|
2 years
|
|
to determine progression free survival and overall survival.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Jacobsen, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2007
Primary Completion (Actual)
July 25, 2023
Study Completion (Actual)
July 25, 2023
Study Registration Dates
First Submitted
June 15, 2007
First Submitted That Met QC Criteria
June 15, 2007
First Posted (Estimated)
June 18, 2007
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-275
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.