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Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Study of Promace-Cytabom With Trimethoprim Sulfamethoxazole, Zidovudine (AZT), and Granulocyte Colony Stimulating Factor (G-CSF) in Patients With AIDS-Related Lymphoma, Phase II

OBJECTIVES: I. Assess the response rate of AIDS-related lymphoma to ProMACE-CytaBOM
(cyclophosphamide, doxorubicin, etoposide, 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.

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 etoposide 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.

Inclusion 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

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

PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for lymphoma

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

every 3 months while on protocol treatment

Safety Issue:


Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University


United States: Federal Government

Study ID:




Start Date:

June 1994

Completion Date:

July 2011

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • AIDS-related diffuse mixed cell lymphoma
  • AIDS-related diffuse small cleaved cell lymphoma
  • Lymphoma
  • Lymphoma, AIDS-Related



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
MBCCOP - LSU Medical Center New Orleans, Louisiana  70112
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
MBCCOP - University of South Alabama Mobile, Alabama  36688
Veterans Affairs Medical Center - Long Beach Long Beach, California  90822
Beckman Research Institute, City of Hope Los Angeles, California  91010
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Texas Tech University Health Science Center Lubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences University Portland, Oregon  97201-3098
Puget Sound Oncology Consortium Seattle, Washington  98109