Status:
COMPLETED
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 an...
Detailed Description
OBJECTIVES: Primary * Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission. Secondary * Evaluate the emergence of an immun...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00963521
Start Date
June 1 2008
Last Update
May 13 2011
Active Locations (1)
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1
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273