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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
N/A
Not Enrolling
Both
Lymphoma

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:

Interventional

Study Design:

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

Outcome Measure:

Response

Outcome Time Frame:

every 3 months while on protocol treatment

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

CDR0000063620

NCT ID:

NCT00002571

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
MBCCOP - University of South AlabamaMobile, Alabama  36688
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
Beckman Research Institute, City of HopeLos Angeles, California  91010
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Texas Tech University Health Science CenterLubbock, Texas  79415
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
CCOP - Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Puget Sound Oncology ConsortiumSeattle, Washington  98109