Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 11/1/2018 |
| Start Date: | June 2007 |
| End Date: | October 2024 |
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.
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.
- 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.
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.
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
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