Clinical Trial: Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is currently recruiting patients.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractorylow-grade non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent diffuse small lymphocytic/marginal zone lymphoma
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: growth factor antagonist therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Thalidomide in Patients With Relapsed or Refractory Low-Grade Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory low-grade non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Follicular grades I, II, or III
  • B-cell small lymphocytic lymphoma
  • Bidimensionally measurable disease
  • Greater than 1 cm in each dimension by physical exam, x-ray, MRI, or CT scan
  • The following are not considered measurable:
  • Barium studies
  • Ascites or pleural effusions
  • Bony disease
  • Bone marrow
  • No marginal zone lymphoma
  • No known lymphomatous involvement of the CNS, including parenchymal or leptomeningeal involvement NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • ECOG 0-1 OR
  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

Hepatic:

  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2 times normal

Neurologic:

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Regardless of fertility status:
  • Female patients must use at least 1 highly active method of contraception AND 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation
  • Male patients must use effective barrier contraception during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No more than 2 prior antibody treatments

Chemotherapy:

  • No more than 3 prior chemotherapy regimens
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent bisphosphonates (e.g., zoledronate)

Location and Contact Information


Alabama
      Northeast Alabama Regional Medical Center, Anniston,  Alabama,  36207,  United States; Recruiting
Thomas W. Twele, MD  256-236-2549 

California
      Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Alan T. Lefor, MD  310-423-5874    Alan.Lefor@cshs.org 

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Stephen L. Seagren, MD  858-657-7020 

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States; Recruiting
Alan Paul Venook, MD  800-888-8664 

      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States; Recruiting
Saeeda Kirmani, MD  619-552-8585 ext. 3356    skirmani@ucsd.edu 

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States; Recruiting
Patricia A. Cornett, MD  415-221-4810 ext. 3423    patricia.cornett@med.va.gov 

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
Stephen Scott Grubbs, MD  302-623-4100 

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States; Recruiting
Edward P. Gelmann, MD  202-444-7303    gelmanne@georgetown.edu 

      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States; Recruiting
Steven H. Krasnow, MD  202-745-8178    krasnow.steven@washington.va.gov 

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States; Recruiting
Joseph Drabick, MD  202-782-6751 

Florida
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States; Recruiting
Luis Ramon Barreras, MD, FACP  954-771-0692 

      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States; Recruiting
Rogerio C. Lilenbaum, MD  305-674-2625 

      Florida Hospital Cancer Institute, Orlando,  Florida,  32804,  United States; Recruiting
Jane Crofton, RN, BSN, OCN  407-303-2090 

      Memorial Regional Hospital Comprehensive Cancer Center, Hollywood,  Florida,  33021,  United States; Recruiting
Atif M. Hussein, MD  954-986-6363 

      Palm Beach Cancer Institute, West Palm Beach,  Florida,  33401,  United States; Recruiting
Robert J. Jacobson, M B, ChB, FACP, FRCP(C)  561-366-4150 

Illinois
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States; Recruiting
John W. Kugler, MD  309-636-3605 

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States; Recruiting
Keith L. Shulman, MD  773-564-5022    KShulman@weisshospital.org 

      Saint Anthony Medical Center, Rockford,  Illinois,  61108,  United States; Recruiting
Richard E. Nora, MD  815-227-2273    richard.e.nora@osfhealthcare.org 

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Karen Wendling  773-834-7424 

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States; Recruiting
Thomas E. Lad, MD  312-996-2046 

      West Suburban Center for Cancer Care, River Forest,  Illinois,  60305,  United States; Recruiting
John L. Showel, MD  708-763-2700 

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
Rafat H. Ansari, MD, FACP  574-284-7977 

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
Sreenivasa Rao Nattam, MD  219-484-8830    ledgar@fwmoh.com 

Iowa
      Hematology Oncology Associates of the Quad Cities, Bettendorf,  Iowa,  52722,  United States; Recruiting
S. Donald Zaentz, MD, FACP  563-355-7733    sdzaente@rccqc.com 

      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Gerald H. Clamon, MD  319-356-1932 

Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States; Recruiting
Daniel C. Scullin, MD  502-897-1166 

Maryland
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States; Recruiting
Martin J. Edelman, MD  410-328-2703    medelman@umm.edu 

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
George P. Canellos, MD  617-632-3470    george_canellos@dfci.harvard.edu 

      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States; Recruiting
Pankaj Bhargava  508-856-6884    bhargavp@ummhc.org 

Michigan
      Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph,  Michigan,  49085,  United States; Recruiting
Eric P. Lester, MD  269-982-4963 

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Bruce A. Peterson, MD  612-624-5631 

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States; Recruiting
Vicki A. Morrison, MD  612-725-2000 ext. 4135    morri002@tc.umn.edu 

Missouri
      Barnes-Jewish Hospital, St. Louis,  Missouri,  63110,  United States; Recruiting
Nancy Bartlett, MD  314-747-3000 

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
Jorge C. Paradelo, MD  816-823-0555    kccop@kccop.org 

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Michael C. Perry, MD  573-882-4979    perrym@health.missouri.edu 

      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States; Recruiting
Alan Philip Lyss, MD  314-996-5514    alyss@bjc.org 

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States; Recruiting
William P. Patterson, MD  573-882-6163 

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Margaret Anne Kessinger, MD  402-559-7511    makessin@unmc.edu 

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States; Recruiting
John Allan Ellerton, MD, CM  702-384-0013    k.vavwagenen@sncrf.com 

      Veterans Affairs Medical Center - Las Vegas, Las Vegas,  Nevada,  89106,  United States; Recruiting
Chitha R. Hulugalle, MD  702-696-3000 

New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States; Recruiting
Douglas Jay Weckstein, MD  603-622-6484    d.weckstein@nhoh.com 

      Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon,  New Hampshire,  03756-0002,  United States; Recruiting
Marc Stuart Ernstoff, MD  603-650-5534    Marc.S.Ernstoff@Hitchcock.org 

New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103,  United States; Recruiting
Edison Catalano, MD  856-342-2506 

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Vincent P. Vinciguerra, MD  516-562-8915 

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States; Recruiting
Jeffrey J. Kirshner, MD  315-472-7504 

      Elmhurst Hospital Center, Elmhurst,  New York,  11373,  United States; Recruiting
Vladimir Benisovich, MD  718-334-3723    beniso@aol.com 

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Clifford A. Hudis, MD  212-639-6483 

      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States; Recruiting
Lewis R. Silverman, MD  212-241-5520    lewis.silverman@mssm.edu 

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States; Recruiting
Scott Wadler, MD  212-746-2844 

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Daniel R. Budman, MD  516-562-8958 

      Queens Cancer Center of Queens Hospital, Jamaica,  New York,  11432,  United States; Recruiting
Hans W. Grunwald, MD  718-883-4118    hans.grunwald@mssm.edu 

      University Hospital at State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-464-8200    grazians@upstate.edu 

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States; Recruiting
Lynn Marie Steinbrenner, MD  716-862-3191    lynn.steinbrenner@med.va.gov 

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States; Recruiting
Stephen L. Graziano, MD  315-476-7461 

North Carolina
      Cape Fear Valley Health System, Fayetteville,  North Carolina,  28302-2000,  United States; Recruiting
Kamal M. Bakri, MD  910-609-6910 

      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States; Recruiting
James N. Atkins, MD  336-777-3036 

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
David Duane Hurd, MD  336-716-2088    dhurd@wfubmc.edu 

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
Jeffrey Crawford, MD  919-684-5195    crawf006@mc.duke.edu 

      FirstHealth Moore Regional Hospital, Pinehurst,  North Carolina,  28374,  United States; Recruiting
Ellen M. Willard, MD  910-295-9205 

      Lenoir Memorial Hospital Cancer Center, Kinston,  North Carolina,  28503-1678,  United States; Recruiting
Peter R. Watson, MD  919-559-2200 Ext. 201 

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States; Recruiting
Thomas C. Shea, MD  919-966-7746 

      New Hanover Regional Medical Center, Wilmington,  North Carolina,  28402-9025,  United States; Recruiting
Cyrus A. Kotwall, MD  910-763-4630 

      NorthEast Oncology Associates, Concord,  North Carolina,  28025,  United States; Recruiting
James Grier Wall, MD  704-783-1370    jwall@northeastmedical.org 

      Veterans Affairs Medical Center - Asheville, Asheville,  North Carolina,  28805,  United States; Recruiting
John C. Lucke, MD  828-299-2540 

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States; Recruiting
Michael J. Kelley, MD  919-286-0411 

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Clara D. Bloomfield, MD  614-293-7518    bloomfield-1@medctr.osu.edu 

Oklahoma
      Oklahoma University Medical Center at University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Howard Ozer, MD, PhD  405-271-4022 

Pennsylvania
      Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
Richard K. Shadduck, MD  412-578-4355    rshadduck@msn.com 

Rhode Island
      Lifespan: The Miriam Hospital, Providence,  Rhode Island,  02906,  United States; Recruiting
William M. Sikov, MD  401-793-7151    wsikov@lifespan.org 

Texas
      Veterans Affairs Medical Center - Dallas, Dallas,  Texas,  75216,  United States; Recruiting
Barry Levinson, MD  214-648-4193 

Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States; Recruiting
L. Herbert Maurer, MD  802-442-1290    mauh@phin.org 

      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States; Recruiting
Hyman Bernard Muss, MD  802-847-3827 

      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States; Recruiting
Joseph F. O'Donnell, MD  802-295-9363 ext. 5480    joseph.odonnell@dartmouth.edu 

Virginia
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States; Recruiting
Stefan M. Gorsch, MD  434-982-8410 

      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States; Recruiting
John D. Roberts, MD  804-828-0450 

      Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke,  Virginia,  24014,  United States; Recruiting
Paul D. Richards, MD  540-982-0237    paul.richards@usoncology.com 

      Virginia Oncology Associates - Norfolk, Norfolk,  Virginia,  23502,  United States; Recruiting
Paul R. Conkling, MD  757-466-8683 

West Virginia
      St. Mary's Medical Center, Huntington,  West Virginia,  25701,  United States; Recruiting
Gerrit A. Kimmey, MD  304-528-4645 

Puerto Rico
      University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan,  00936-5067,  Puerto Rico; Recruiting
Enrique Velez-Garcia, MD  787-754-0101 Ext.2020 

Study chairs or principal investigators

David L. Grinblatt, MD,  Study Chair,  Evanston Northwestern Health Care - Evanston Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068832; CALGB-50002
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022581
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005