Follicular LymphomaPhase 1NCT00487305
Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
A Phase 1 study testing Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells in people with Follicular Lymphoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 25 Jul 2023
- Phase
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
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.
- Conditions
- Follicular Lymphoma
- Being tested
- Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells
- Keywords
- GM-CSF, vaccine, K562
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lethally Irradiated Lymphoma cells with GM-CSF K562 CellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Biological/Vaccine | Experimental | 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.
-------------------------------------------------------------------------------- Receives: Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
To describe the biologic activity of the study vaccine
Measured: 2 years
to determine tumor overall response rate as well as complete and partial response rates
Measured: 2 years
to determine progression free survival and overall survival.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startJun 2007
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Jacobsen, MD, Dana-Farber Cancer Institute
- Investigators
- Eric Jacobsen, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487305
- Sponsor's protocol ID
- 06-275
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00487305
- Acronym / sponsor ID
- 06-275
- Conditions
- Follicular Lymphoma
- Keywords
- GM-CSF, vaccine, K562
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2007 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological/Vaccine | Experimental | Biological: Lethally Irradiated Lymphoma cells with GM-CSF K562 CellsBiological/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. -------------------------------------------------------------------------------- |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lethally Irradiated Lymphoma cells with GM-CSF K562 CellsDose 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 | Biological/Vaccine |
Primary outcome
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
3 secondary outcomes
To describe the biologic activity of the study vaccine
Time frame: 2 years
to determine tumor overall response rate as well as complete and partial response rates
Time frame: 2 years
to determine progression free survival and overall survival.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 39034493Jacobsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jacobsen, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells in people with Follicular Lymphoma, run by Dana-Farber Cancer Institute 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 10 inclusion and 10 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 15 Aug 2024. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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). 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 NCT00487305, which also lists 1 linked publication.
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 15 Aug 2024.