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Spots Global Cancer Trial Database for Study of Bone Marrow and Blood Samples in Patients With Untreated Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Enrolled on Clinical Trial CALGB-9621 or CALGB-9720

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Trial Identification

Brief Title: Study of Bone Marrow and Blood Samples in Patients With Untreated Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Enrolled on Clinical Trial CALGB-9621 or CALGB-9720

Official Title: Multidrug Resistance Studies in Acute Myeloid Leukemia

Study ID: NCT01004965

Conditions

Leukemia

Study Description

Brief Summary: This research study is looking at bone marrow and blood samples in patients with untreated acute myeloid leukemia or acute lymphoblastic leukemia enrolled on clinical trial CALGB-9621, CALGB-9720, CALGB 19808, and CALGB 10201. Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed Description: OBJECTIVES: I. Determine Pgp antigen expression and Pgp-mediated functional multidrug resistance (MDR) in pretreatment acute myeloid leukemia (AML) cells from adult patients enrolled on CALGB clinical trials of PSC-833 Pgp modulation. II. Correlate Pgp-mediated MDR with patient pretreatment characteristics including age, immunophenotype, and karyotype. III. Correlate Pgp expression, function, and in vitro modulation by PSC-833 with treatment outcome in previously untreated AML patients treated on CALGB Pgp modulation trials. IV. Determine Pgp expression and function in AML cells from patients with refractory or relapsed leukemia following induction chemotherapy administered with or without PSC-833. V. Correlate acquisition of drug resistance with changes in expression of other antigens and gain or loss of leukemic populations at relapse in these patients. VI. Determine the role of other mediators, including multidrug resistance-associated protein (MRP) and lung-resistance protein (LRP), in mediating MDR in these patients at diagnosis and with relapsed or refractory disease after induction chemotherapy with or without PSC-833. VII. Determine the frequency of Pgp-, MRP-, and LRP- mediated MDR in adult acute lymphoblastic leukemia cells and correlate this frequency with pretreatment characteristics and treatment outcome in these patients. OUTLINE: Samples are obtained: 1) pretreatment, 2) at the time of documentation of refractory disease in acute myeloid leukemia (AML) patients who do not achieve complete response (CR) after induction therapy, and 3) at the time of first relapse in patients who achieve CR. Marrow cells are preferentially used for all samples, but peripheral blood is acceptable if marrow is not available and the blood contains 20% or more blasts. Pgp expression is measured using flow cytometry. AML samples are analyzed by immunoenzyme techniques (IET) using antibodies to CD33, CD34, and MRK16. B-lineage acute lymphoblastic leukemia (ALL) samples are analyzed by IET using antibodies to CD19, CD34, and MRK16. The antibodies used to analyze T-cells include CD7 and CD34. Pgp function is measured by growing cells in the presence of PSC-833 in vitro and then measuring Pgp expression as above. Multidrug resistance-associated protein (MRP) is measured using IET with the MRPm6 antibody. Lung-resistance protein (LRP) is measured with IET and the LRP56 antibody. These results are correlated with flow cytometry results.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Naval Medical Center - San Diego, San Diego, California, United States

Tunnell Cancer Center at Beebe Medical Center, Lewes, Delaware, United States

CCOP - Christiana Care Health Services, Newark, Delaware, United States

Walter Reed Army Medical Center, Washington, District of Columbia, United States

University of Illinois Cancer Center, Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

Menorah Medical Center, Overland Park, Kansas, United States

Saint Luke's Hospital - South, Overland Park, Kansas, United States

Shawnee Mission Medical Center, Shawnee Mission, Kansas, United States

CancerCare of Maine at Eastern Maine Medical Center, Bangor, Maine, United States

Union Hospital Cancer Program at Union Hospital, Elkton, Maryland, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

Truman Medical Center - Hospital Hill, Kansas City, Missouri, United States

Saint Luke's Cancer Institute at Saint Luke's Hospital, Kansas City, Missouri, United States

St. Joseph Medical Center, Kansas City, Missouri, United States

North Kansas City Hospital, Kansas City, Missouri, United States

Heartland Hematology Oncology Associates, Incorporated, Kansas City, Missouri, United States

CCOP - Kansas City, Kansas City, Missouri, United States

Research Medical Center, Kansas City, Missouri, United States

Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States

Liberty Hospital, Liberty, Missouri, United States

Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Saint Joseph Oncology, Incorporated, Saint Joseph, Missouri, United States

Methodist Estabrook Cancer Center, Omaha, Nebraska, United States

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York, United States

Monter Cancer Center of the North Shore-LIJ Health System, Lake Success, New York, United States

CCOP - North Shore University Hospital, Manhasset, New York, United States

Don Monti Comprehensive Cancer Center at North Shore University Hospital, Manhasset, New York, United States

Long Island Jewish Medical Center, New Hyde Park, New York, United States

Mount Sinai Medical Center, New York, New York, United States

SUNY Upstate Medical University Hospital, Syracuse, New York, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States

Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States

Kinston Medical Specialists, Kinston, North Carolina, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, United States

McLeod Regional Medical Center, Florence, South Carolina, United States

Contact Details

Name: Maria R. Baer, MD

Affiliation: University of Maryland Greenebaum Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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