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GM-CSF Secreting Leukemia Cell Vaccinations After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome or Refractory Acute or Advanced Chronic Myeloid Leukemia


N/A
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome RAEB-I or RAEB-II, Refractory Acute Myeloid Leukemia, Refractory CML Myeloid Blast Crisis

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Trial Information

GM-CSF Secreting Leukemia Cell Vaccinations After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome or Refractory Acute or Advanced Chronic Myeloid Leukemia


- This trial can be divided into three phases: 1) Pre-transplant phase; 2) Reduced
intensity transplant phase; 3) Vaccination phase.

- Pre-transplant phase: Once a suitable donor has been identified, the participant will
undergo a battery of standard pre-transplant tests and procedure to collect their
leukemia cells for vaccine generation. Blood tests, heart function test, pulmonary
function test, tuberculosis test, bone marrow aspirate and biopsy, and leukemia cell
collection through leukapheresis.

- Allogeneic reduced intensity stem cell transplant phase: The transplant phase of the
study will begin when the participant is admitted to the hospital to receive the
chemotherapy and stem cell transplant. The minimum duration of hospitalization for the
procedure is approximately 8 days. In the week before the participant receives the stem
cells, they will be treated with chemotherapy through a central line. The goal of
chemotherapy is to both control the cancer and suppress the immune system so that the
body will not reject the donor stem cells.

- Just prior to and immediately following the infusion of stem cells, participants will
receive medications to help prevent graft-versus-host disease (GVHD), a common
complication of transplant where the donor's immune cells attack the body. After the
transplant, participants will also take antibiotic medication to help prevent possible
infections.

- Sargramostim (GM-CSF, leukine), a white blood cell growth factor, will be given daily
subcutaneously starting the day after the stem cell transplant until blood counts have
recovered.

- After the stem cell infusion, participants will be examined and have blood tests weekly
for 1 month. Between 30-45 days after the transplant, a bone marrow biopsy will be
performed to assess the status of the disease and to look for evidence of the donor's
cells in the bone marrow.

- Vaccination Phase: After the bone marrow biopsy 30-45 days after the transplant, the
participant will begin to receive the vaccinations. The vaccine will be administered
subcutaneously and intradermally on the arm, leg, or abdomen 6 times over a period of 9
weeks. The first 3 vaccinations will occur once a week for 3 consecutive weeks, and
the last 3 vaccines will be given once every other week over 6 weeks. All vaccinations
may be given as an outpatient in the clinic. During this period of time, participants
will be closely monitored on a weekly basis to monitor for side effects. Before the
first and after the fifth and sixth vaccinations, a small amount of the participants
leukemia cells will be injected under the skin to see if the immune system will react
against it and cause redness and swelling.

- About 4 weeks after the last vaccination (6th), a bone marrow aspirate and biopsy will
be performed to assess the status of the disease.

- After the 1st and 5th vaccinations, a skin biopsy will be performed to assess for
response at the vaccine site. These biopsies are relatively simple outpatient
procedures.


Inclusion Criteria:



- AML, MDS-RAEB or RAEB-T, CML, myeloid blast crisis not in remission or CML
accelerated phase. Subjects must have > 5% blasts in bone marrow or peripheral blood
prior to admission for transplant.

- HLA 6/6 matched related or unrelated donor available

- ECOG Performance Statue 0-2

- 18 years of age or older

Exclusion Criteria:

- Uncontrolled infection

- Leukemia with active CNS involvement

- Serum creatinine greater than 2.0 mg/dl

- ALT or AST greater than 3 x ULN

- Total bilirubin greater than 2.0 mg/dl

- Positive HIV or HTLV-1 serology

- Prior allogeneic stem cell transplant

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility as measured by ability to generate sufficient vaccine, and ability for this patient population to initiate vaccination between day 30 to day 45 after transplant.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Vincent Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

04-023

NCT ID:

NCT00426205

Start Date:

June 2004

Completion Date:

September 2009

Related Keywords:

  • Myelodysplastic Syndrome RAEB-I or RAEB-II
  • Refractory Acute Myeloid Leukemia
  • Refractory CML Myeloid Blast Crisis
  • GM-CSF
  • GVAX
  • Cancer vaccine
  • blood stem cell transplantation
  • MDS
  • AML
  • CML
  • Anemia, Refractory, with Excess of Blasts
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115