Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed over 15 NCI MDA-DM-93058 NCI-T93-0088D, NCT00002524, T93-0088

Objectives

I.  Develop an effective chemotherapy regimen with mild immunosuppressive and 
myelosuppressive properties to treat patients with AIDS-related lymphoma (ARL) 
who have severe T4 lymphopenia.

II.  Estimate the CR rate, lymphoma-free survival, and overall survival of 
non-T4 lymphopenic patients and patients who present with nonbulky Ann Arbor 
stage I ARL treated with standard regimens of known effectiveness.

III.  Evaluate the effects on long-term outlook of concurrent antiretroviral 
therapy, prophylactic antibiosis with trimethoprim/sulfamethoxazole or 
aerosolized pentamidine, and prn use of granulocyte colony-stimulating factor 
for severe myelosuppression.

Entry Criteria

Disease Characteristics:

Previously untreated, HIV-related intermediate- and high-grade lymphoma with
no previous diagnosis of Kaposi's sarcoma
  Pathology reviewed at M.D. Anderson Cancer Center

Prior/Concurrent Therapy:

No prior therapy for lymphoma
No concurrent chemotherapy

Patient Characteristics:

Age:
  Over 15

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  For patients with T4 less than 200 and those with primary brain lymphoma:
     Creatinine no greater than 2.0 mg/dL (unless entry approved by principal
     investigator)

Other:
  Serious intercurrent illness must be discussed with the principal
     investigator
  Infectious disease consultation required for complex infections
  Medications for other conditions allowed provided no adverse interaction
     with protocol therapy occurs
  No previously diagnosed Kaposi's sarcoma or other malignancy

Expected Enrollment

Up to 92 patients (10 for Regimen A, 28 for Regimen B, 54 for Regimen C) will 
be entered over 3 years.  If there are no CRs among the first 6 patients on 
Regimens A and B or the first 19 patients on Regimen C, accrual to that 
regimen will cease.  If more than 4 infectious deaths occur among the first 10 
patients or if the rate of disease progression exceeds 20% on any regimen, 
further accrual to that regimen will cease.

Outline

Patients are assigned to Regimens A, B, and C according to histology and 
extent of disease and the degree of immunosuppression as follows:

Regimen A:  Patients with Ann Arbor stage I intermediate grade or 
immunoblastic lymphoma with measurable nonbulky disease (less than 7 cm), low 
LDH (less than 686), and no prior opportunistic infection irrespective of T4 
count; also those with nonmeasurable stage I extranodal primaries 
(infiltration of less than 2/3 of an organ site, e.g., stomach, rectum, 
esophagus, sinus cavity) irrespective of T4 count.

Regimen B:  All patients (except primary brain lymphoma patients) not assigned 
to Regimen A who have T4 counts of at least 200 and no history of 
opportunistic infection; includes all stages of small noncleaved cell lymphoma 
and bulky stage I and stages II-IV intermediate grade and immunoblastic 
lymphoma.

Regimen C:  Patients not assigned to Regimen A or B, i.e., those with T4 
counts less than 200 and/or a history of opportunistic infection and those 
with primary brain lymphoma.

The following acronyms are used:
  ARA-C    Cytarabine, NSC-63878
  BLEO     Bleomycin, NSC-125066
  CDDP     Cisplatin, NSC-119875
  CF       Leucovorin calcium, NSC-3590
  CTX      Cyclophosphamide, NSC-26271
  DOX      Doxorubicin, NSC-123127
  5-FU     Fluorouracil, NSC-19893
  G-CSF    Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629
  IFF      Ifosfamide, NSC-109723
  MePRDL   Methylprednisolone succinate
  Mesna    Mercaptoethane sulfonate, NSC-113891
  MTX      Methotrexate, NSC-740
  PRED     Prednisone, NSC-10023
  VCR      Vincristine, NSC-67574
  VP-16    Etoposide, NSC-141540
  ZDV      Zidovudine, NSC-602670

Regimen A:  5-Drug Combination Chemotherapy followed by Radiotherapy.  
CHOP-BLEO:  CTX; DOX; VCR; PRED; BLEO; followed by involved-field irradiation 
with megavoltage equipment.

Regimen B:  4-Drug Combination Chemotherapy alternating with 3-Drug 
Combination Chemotherapy followed, as indicated, by Radiotherapy.  ASHAP:  
DOX; MePRDL; ARA-C; CDDP; alternating with IMVP-16:  IFF/Mesna; MTX/CF; VP-16; 
followed, in selected patients with initially bulky localized disease, by 
involved-field irradiation with megavoltage equipment.

Regimen C:  2-Drug Combination Chemotherapy with Drug Modulation followed, as 
indicated, by Radiotherapy.  FLEP:  5-FU/CF/CDDP; followed, in selected 
patients with initially bulky localized disease, by involved-field irradiation 
with megavoltage equipment.  Prior to starting chemotherapy, patients with 
primary brain lymphoma receive a course of cranial irradiation using 
accelerator beams with photon energies of 6-15 MV.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Peter McLaughlin, MD, Protocol chair		Ph: 713-792-2860; 800-392-1611 Email: pmclaugh@mdanderson.org

Registry Information
Official Title		PILOT STUDY IN AIDS-RELATED LYMPHOMAS
Trial Start Date		1993-06-28
Registered in ClinicalTrials.gov		NCT00002524
Date Submitted to PDQ		1993-06-28
Information Last Verified		2000-08-01