Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
NCT ID: NCT00002524
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
1993-06-30
2005-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
Detailed Description
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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.
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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Regimen A
Regimen A: 5-Drug Combination Chemotherapy followed by Radiotherapy.
Bleomycin Sulfate
Cyclophosphamide
Doxorubicin Hydrochloride (DOX)
Pentamidine
Prednisone
Trimethoprim-Sulfamethoxazole
Vincristine Sulfate
Zidovudine (AZT)
Radiation Therapy
Regimen B
Regimen B: 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy
Filgrastim
Cytarabine
Doxorubicin Hydrochloride (DOX)
Etoposide
Ifosfamide
Methotrexate
Methylprednisolone
Pentamidine
Trimethoprim-Sulfamethoxazole
Zidovudine (AZT)
Radiation Therapy
Regimen C
Regimen C: 2-Drug Combination Chemotherapy with Drug Modulation followed, as indicated, by Radiotherapy.
Filgrastim
Cisplatin
Fluorouracil
Leucovorin calcium
Pentamidine
Trimethoprim-Sulfamethoxazole
Zidovudine (AZT)
Radiation Therapy
Interventions
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Bleomycin Sulfate
Filgrastim
Cisplatin
Cyclophosphamide
Cytarabine
Doxorubicin Hydrochloride (DOX)
Etoposide
Fluorouracil
Ifosfamide
Leucovorin calcium
Methotrexate
Methylprednisolone
Pentamidine
Prednisone
Trimethoprim-Sulfamethoxazole
Vincristine Sulfate
Zidovudine (AZT)
Radiation Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Peter W. McLaughlin, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center Orlando
Orlando, Florida, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-DM-93058
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-T93-0088D
Identifier Type: -
Identifier Source: secondary_id
CDR0000078316
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM93-058
Identifier Type: -
Identifier Source: org_study_id