NCT00100971TerminatedPhase 1
Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Boston Medical Center
- Enrollment
- 9
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia.
Detailed Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia.
- Determine the toxicity of this vaccine in these patients.
Secondary
- Determine whether cellular immunity can be induced by this vaccine in these patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy
- •Newly diagnosed
- •Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood
- •No clinical evidence of CNS leukemia
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No clinically significant autoimmune disease
- •No other active malignancy except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 3 months since prior immunotherapy
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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