Clinical Trial: Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Antiviral therapy may be effective treatment for AIDS -related lymphoma. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and antiviral therapy in treating patients who have AIDS-related lymphoma.

Condition Treatment or Intervention Phase
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
 Drug: bleomycin
 Drug: co-trimoxazole
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: prednisone
 Drug: vincristine
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of ProMACE-CytaBOM with Co-Trimoxazole, Filgrastim (G-CSF) and Antiretroviral Therapy in Patients with AIDS-Related Lymphoma

Further Study Details: 

Study start: June 1994

OBJECTIVES: I. Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM (cyclophosphamide, doxorubicin, etopside, prednisone, cytarabine, bleomycin, vincristine, methotrexate). II. Assess the toxic effects of ProMACE-CytaBOM in patients with AIDS-related lymphoma. III. Evaluate whether the incorporation of filgrastim (G-CSF) into the regimen allows treatment with full doses of the myelotoxic agents in these patients. IV. Determine whether intensive CNS treatment with intrathecal cytarabine and whole-brain irradiation prevents meningeal relapse or controls meningeal lymphomatous involvement in these patients.

PROTOCOL OUTLINE: Patients are stratified according to participating institution and descriptive factors: histopathology (diffuse large cleaved/noncleaved and immunoblastic lymphomas vs all others), CD4 count (less than 50 vs 50 or more cells/mm3), prior opportunistic infection (yes vs no), performance status (0 and 1 vs 2), concurrent AZT (yes vs no), concurrent protease inhibitors (yes vs no), marrow involvement (yes vs no). Patients receive ProMACE-CytaBOM regimen as follows: Cyclophosphamide, doxorubicin, and etopside IV on day 1 Cytarabine, bleomycin, vincristine, and methotrexate IV on day 8 Oral prednisone on days 1-14 Oral leucovorin calcium every 6 hours for 4 doses on day 9 Patients also receive filgrastim (G-CSF) subcutaneously on days 9-20 and oral co-trimoxazole 3 days a week throughout treatment, plus antiretroviral therapy at the discretion of the treating physician. Treatment repeats every 21 days for a maximum of 6 courses. Patients with progressive disease are removed from study after 2 courses. Remaining patients receive an additional 2 treatment courses and are then restaged. Patients without stable or progressive disease receive 2 more courses in the absence of unacceptable toxicity. Patients with positive bone marrow at study entry receive CNS prophylaxis with 5 evenly spaced doses of intrathecal cytarabine during the first 2 treatment courses and on day 1 of each subsequent course. Patients with positive CSF cytology at study entry receive intrathecal cytarabine on days 1-5 of the first treatment course and on day 1 of each subsequent course if CSF negative after 5 daily doses. Patients whose CSF remains positive after 5 days receive 5 evenly spaced doses of intrathecal methotrexate during the second treatment course. Patients with negative bone marrow and CSF cytology at study entry receive 5 evenly spaced doses of intrathecal cytarabine within 1 month of systemic therapy. All patients achieving a complete or partial response following systemic therapy and intrathecal cytarabine receive cranial irradiation to all meningeal surfaces. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over approximately 2 years.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven intermediate or high grade non-Hodgkin's lymphoma of one of the following histologies: Follicular, predominantly large cell; Diffuse, small cleaved cell Diffuse mixed, small and large cell; Diffuse, large cell (cleaved or noncleaved); Immunoblastic, large cell Small noncleaved cell, Burkitt's or non-Burkitt's; No lymphoblastic lymphoma
  • Prior diagnosis of AIDS or HIV positivity required; Confirmation of HIV antibody status by Western blot mandatory
  • Bidimensionally measurable or evaluable disease
  • No primary CNS lymphoma
  • Concurrent registration on protocol SWOG-8947 (central serum repository) required

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: Over 18
  • Performance status: SWOG 0-2
  • Hematopoietic: Absolute neutrophil count at least 500/mm3; Platelet count at least 75,000/mm3
  • Hepatic: AST no greater than 1.5 times normal; Alkaline phosphatase no greater than 1.5 times normal; LDH no greater than 1.5 times normal; PT/PTT normal
  • Renal: Creatinine no greater than 2.0 times normal; Creatinine clearance at least 60 mL/min
  • Cardiovascular: No serious abnormalities on EKG; No history of severe coronary artery disease; No history of cardiomyopathy, congestive heart failure, or arrhythmia
  • Other: No active uncontrolled infection; No active second malignancy within 5 years except adequately treated nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception

Location Information


Alabama
      MBCCOP - University of South Alabama, Mobile,  Alabama,  36688,  United States

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

      Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,  Arizona,  85012,  United States

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States

California
      Beckman Research Institute, City of Hope, Los Angeles,  California,  91010,  United States

      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States

      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

      Veterans Affairs Medical Center - Long Beach, Long Beach,  California,  90822,  United States

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

      Tripler Army Medical Center, Honolulu,  Hawaii,  96859-5000,  United States

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States

      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States

Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States

      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

Ohio
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Dayton, Kettering,  Ohio,  45429,  United States

      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States

Oklahoma
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States

      Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234,  United States

      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      Texas Tech University Health Science Center, Lubbock,  Texas,  79423,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-1329,  United States

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78284,  United States

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

      Puget Sound Oncology Consortium, Seattle,  Washington,  98109,  United States

      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Lode J. Swinnen,  Study Chair,  Southwest Oncology Group   

More Information

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

Study ID Numbers:  CDR0000063620; SWOG-9320
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002571
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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

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