Evaluating Cell Damage in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Fanconi Anemia; in Patients Who Were Exposed to Alkylating Agents; and in Healthy Volunteers - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00899795

Purpose

RATIONALE: Studying samples of bone marrow from patients with cancer and from healthy volunteers in the laboratory may help doctors learn more about changes that occur in bone marrow stromal (connective tissue) cells.

It may also help doctors understand the effects of alkylating agents on bone marrow stromal cells.

PURPOSE: This laboratory study is evaluating stromal cells in patients with acute myeloid leukemia, myelodysplastic syndromes, or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.

Condition	Intervention
Leukemia Myelodysplastic Syndromes	Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Other: flow cytometry Procedure: biopsy

Study Type:	Observational
Official Title:	Stromal Injury and Clonal Adaptation in Myelodysplasia

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Abnormal stromal function [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clonal progenitors resistant to selected extracellular apoptotic cells [ Designated as safety issue: No ]
Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes [ Designated as safety issue: No ]
Influence of cytotoxic agents on supportive function of the bone marrow stroma [ Designated as safety issue: No ]
Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2002

Detailed Description:

OBJECTIVES:

Primary

Determine abnormal stromal function in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.

Secondary

Determine whether clonal progenitors from patients with secondary AML or MDS are resistant to selected extracellular apoptotic cues.
Determine whether stromal function in patients with secondary AML or MDS is more aberrant than stromal function in patients with primary AML or MDS.
Determine whether cytotoxic agents known to induce secondary MDS or AML influence the supportive function of the bone marrow stroma.
Determine whether cytoprotective agents reduce both cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells.

OUTLINE: Patients and healthy volunteers undergo bone marrow sample collection. Progenitor cells are grown in culture. Cell survival is quantified by flow cytometric and cytogenetic analysis, sister chromatid exchange, and FISH for chromosome 11 changes (for etoposide-exposed samples only).

PROJECTED ACCRUAL: A total of 24 patients and healthy volunteers will be accrued for this study.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Diagnosis of acute myeloid leukemia or myelodysplastic syndromes and requires bone marrow aspiration/biopsy for clinical purposes
  - Primary or secondary disease
- Diagnosis of Fanconi anemia by positive mitomycin C test (age 5 to 55 years)
- Received prior chemotherapy containing any of the following alkylating agents: mechlorethamine, chlorambucil, cyclophosphamide, melphalan, busulfan, or topoisomerase inhibitors
- Healthy volunteer (age 18 and over), meeting the following criteria:
  - CBC normal
  - WBC > 1,000/mm³
  - Hemoglobin > 10 g/dL
  - Platelet count > 70,000/mm³
No bone marrow metastases
No evidence of non-hematopoietic malignancy

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
No clinical signs and symptoms of acute or subacute infection (viral, bacterial, or fungal infection)
No allergy to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 6 months since prior cytotoxic or immunosuppressive agents
No prior extensive pelvic radiotherapy (> 20 Gy)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899795

Locations

United States, Oregon
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu

Sponsors and Collaborators

Oregon Health and Science University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Grover C. Bagby, MD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000445436, OHSU-HEM-02008-LX
Study First Received:	May 9, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00899795 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
de novo myelodysplastic syndromes

previously treated myelodysplastic syndromes
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
untreated adult acute myeloid leukemia
childhood myelodysplastic syndromes

Study placed in the following topic categories:

Precancerous Conditions
Hematologic Diseases
Fanconi Anemia
Myelodysplastic Syndromes
Anemia
Healthy
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Fanconi's Anemia

Recurrence
Leukemia
Acute Myelocytic Leukemia
Preleukemia
Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Congenital Abnormalities
Bone Marrow Diseases
Alkylating Agents

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 11, 2009