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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


Phase 1
35 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Eric Jacobsen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

06-275

NCT ID:

NCT00487305

Start Date:

June 2007

Completion Date:

October 2024

Related Keywords:

  • Follicular Lymphoma
  • GM-CSF
  • vaccine
  • K562
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115