Leukemia Clinical Trial
Official title:
Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission
Verified date | May 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune
response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how
well it works in treating patients with acute myeloid leukemia in complete remission.
Status | Completed |
Enrollment | 10 |
Est. completion date | |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of acute myelogenous leukemia (AML) - Myelomonocytic (M4) or monocytic (M5) subtype - In second complete remission (CR) or later following CR1 lasting = 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation - No (15;17) translocation - No AML M3 - HLA-A2 positivity - CD14 = 20% on peripheral blood mononuclear cells - Circulating blasts = 10 x 109/L (collected prior to chemotherapy) available - Must not be eligible for HLA-matched allogeneic transplantation - No progressive disease PATIENT CHARACTERISTICS: - Karnofsky performance status 70-100% - Not pregnant or nursing - Fertile patients must use effective contraception - No contraindication to cytopheresis or chemotherapy - No HIV or HTLV positivity - No hepatitis B or C activation - No prior psychological disease - Not deprived of liberty and able to give consent - Must be able to speak and read French - No other cancer except for basal cell or cervical PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No concurrent participation in another clinical study |
Allocation: Non-Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille |
Lead Sponsor | Collaborator |
---|---|
Institut Paoli-Calmettes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events at 6 months | Yes |
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