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Pilot Study in AIDS-Related Lymphomas

Phase 2
15 Years
Not Enrolling

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Trial Information

Pilot Study in AIDS-Related Lymphomas

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.

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

PROJECTED ACCRUAL: 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.

Inclusion 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

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

PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma No concurrent chemotherapy

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients with Clinical Response

Outcome Description:

Clinical Responses categorized by: Complete Response (CR), Partial Response (PR), Minor Response, Stable Disease or Progressive Disease

Outcome Time Frame:

3 Years

Safety Issue:


Principal Investigator

Peter W. McLaughlin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 1993

Completion Date:

October 2005

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS 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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
MD Anderson Cancer Center Orlando Orlando, Florida  32806