Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.

Further Study Information

OBJECTIVES:

Primary

• To estimate the proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC).

• To estimate the proportion of patients with Hodgkin lymphoma with clonal immunoglobulin (Ig) DNA detection in the plasma.

Secondary

• To estimate the agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue.

• To estimate the agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma.

• To estimate the detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma.

• To estimate the detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma.

• To analyze clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki-67 index.

• To estimate the detection rate of clonotypic B-cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma.

OUTLINE: This is a multicenter study.

Blood and tissue samples collected at the time of diagnosis are analyzed for serum free light chain and clonal immunoglobulin (Ig) DNA rearrangements and circulating clonotypic B-cells via PCR.

PROJECTED ACCRUAL: A total of 50 patients (25 with diffuse large B-cell/immunoblastic histologies, 15 with Burkitt lymphoma, and 10 with Hodgkin lymphoma) will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of an untreated aggressive B-cell lymphoma, including:

• Diffuse large B cell/immunoblastic lymphoma

• Burkitt lymphoma

• Hodgkin lymphoma

• Serological documentation of HIV infection by any of the FDA-approved tests

• Available diagnostic material from fresh frozen tissue or formalin-fixed paraffin embedded tissue OR willing to undergo a repeat biopsy (fine needle aspiration is acceptable)

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

AIDS Associated Malignancies Clinical Trials Consortium

Nina Wagner-Johnston

Principal Investigator

Nina Wagner-Johnston, MD

Ph: 314-362-1000

U.S.A.
California
	La Jolla
	Rebecca and John Moores UCSD Cancer Center
		Clinical Trials Office - Rebecca and John Moores UCSD Cancer	Ph: 858-822-5354
			Email: cancercto@ucsd.edu
	Los Angeles
	UCLA Clinical AIDS Research and Education (CARE) Center
		Richard B. Pollard, MD	Ph: 310-206-6414
	Sacramento
	University of California Davis Cancer Center
		Richard Pollard, MD	Ph: 916-734-3711
		Richard Pollard, MD	Principal Investigator
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensi	Ph: 877-827-3222
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		Juan Carlos Ramos, MD	Ph: 305-243-6611
		Juan Carlos Ramos	Principal Investigator
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Cen	Ph: 617-638-8265
Missouri
	St. Louis
	Mallinckrodt Institute of Radiology at Washington University Medical Center
		Clinical Trials Office - Mallinckrodt Institute of Radiology a	Ph: 314-362-1000
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Nina Wagner-Johnston, MD	Ph: 314-362-5654
New York
	Bronx
	Albert Einstein Cancer Center at Albert Einstein College of Medicine
		Samir S. Parekh, MD	Ph: 718-920-4826
			Email: sparekh@montefiore.org
	New York
	Memorial Sloan-Kettering Cancer Center
		Clinical Trials Office - Memorial Sloan-Kettering Cancer Cente	Ph: 646-227-2149
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Kristy Richards, MD	Ph: 919-966-0374
		Kristy Richards, MD	Principal Investigator
Pennsylvania
	Philadelphia
	Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
		David H. Henry, MD	Ph: 215-829-6088
Texas
	Houston
	Baylor University Medical Center - Houston
		Elizabeth Y. Chiao, MD, MPH	Ph: 713-798-8070
		Elizabeth Chiao, MD	Principal Investigator
	Thomas Street Health Center
		Martha Mimms, MD	Ph: 713-873-4000
		Martha Mimms, MD	Principal Investigator
Washington
	Seattle
	Benaroya Research Institute at Virginia Mason Medical Center
		Clinical Trials Office - Benaroya Research Institute	Ph: 206-583-6526

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00981097
Information obtained from ClinicalTrials.gov on January 08, 2013

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