Clinical trial NCT00963521: Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission
Official title: Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Keywords: adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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 and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

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 immune response.
* Determine the relapse rate.
* Assess the occurrence of residual disease.

OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse events at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Christian Chabannon, MD, PhD
References: