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Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002524
Recruitment Status : Completed
First Posted : October 5, 2004
Last Update Posted : July 30, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE October 5, 2004
Last Update Posted Date July 30, 2012
Study Start Date  ICMJE June 1993
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Number of Patients with Clinical Response [ Time Frame: 3 Years ]
Clinical Responses categorized by: Complete Response (CR), Partial Response (PR), Minor Response, Stable Disease or Progressive Disease
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Official Title  ICMJE Pilot Study in AIDS-Related Lymphomas
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.

Detailed Description

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: Bleomycin Sulfate
    Other Names:
    • Blenoxane
    • BLM
  • Biological: Filgrastim
    Other Names:
    • G-CSF
    • Neupogen
  • Drug: Cisplatin
    Other Names:
    • Platinol
    • Plationol-AQ
    • CDDP
  • Drug: Cyclophosphamide
    Other Names:
    • Cytoxan
    • Neosar
  • Drug: Cytarabine
    Other Names:
    • Ara-C
    • Cytosar
    • DepoCyt
    • Cytarabine arabinosine hydrochloride
  • Drug: Doxorubicin Hydrochloride (DOX)
    Other Names:
    • Adriamycin PFS
    • Adriamycin RDF
  • Drug: Etoposide
    Other Name: VePesid
  • Drug: Fluorouracil
    Other Names:
    • 5-FU
    • Adrucil
    • Efudex
    • 5-Fluorouracil
  • Drug: Ifosfamide
    Other Name: Ifex
  • Drug: Leucovorin calcium
    Other Names:
    • Citrovorum
    • Wellcovorin
  • Drug: Methotrexate
  • Drug: Methylprednisolone
    Other Names:
    • Depo-Medrol
    • Medrol
    • Solu-Medrol
  • Drug: Pentamidine
    Other Name: Pentam-300
  • Drug: Prednisone
  • Drug: Trimethoprim-Sulfamethoxazole
    Other Names:
    • SMX
    • Bactrim
    • Cotrim
    • Septra
    • Sulfamethoprim
    • Sulfatrim
    • Sulfoxaprim
    • Trisulfam
    • Uroplus
    • Co-trimoxazole
    • SMX-TMP
  • Drug: Vincristine Sulfate
  • Drug: Zidovudine (AZT)
    Other Name: Retrovir
  • Radiation: Radiation Therapy
    Other Names:
    • RT
    • Radiotherapy
Study Arms  ICMJE
  • Experimental: Regimen A
    Regimen A: 5-Drug Combination Chemotherapy followed by Radiotherapy.
    Interventions:
    • Biological: Bleomycin Sulfate
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin Hydrochloride (DOX)
    • Drug: Pentamidine
    • Drug: Prednisone
    • Drug: Trimethoprim-Sulfamethoxazole
    • Drug: Vincristine Sulfate
    • Drug: Zidovudine (AZT)
    • Radiation: Radiation Therapy
  • Experimental: Regimen B
    Regimen B: 4-Drug Combination Chemotherapy alternating with 3-Drug Combination Chemotherapy followed, as indicated, by Radiotherapy
    Interventions:
    • Biological: Filgrastim
    • Drug: Cytarabine
    • Drug: Doxorubicin Hydrochloride (DOX)
    • Drug: Etoposide
    • Drug: Ifosfamide
    • Drug: Methotrexate
    • Drug: Methylprednisolone
    • Drug: Pentamidine
    • Drug: Trimethoprim-Sulfamethoxazole
    • Drug: Zidovudine (AZT)
    • Radiation: Radiation Therapy
  • Experimental: Regimen C
    Regimen C: 2-Drug Combination Chemotherapy with Drug Modulation followed, as indicated, by Radiotherapy.
    Interventions:
    • Biological: Filgrastim
    • Drug: Cisplatin
    • Drug: Fluorouracil
    • Drug: Leucovorin calcium
    • Drug: Pentamidine
    • Drug: Trimethoprim-Sulfamethoxazole
    • Drug: Zidovudine (AZT)
    • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
46
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2005
Actual Primary Completion Date October 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002524
Other Study ID Numbers  ICMJE DM93-058
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-DM-93058 ( Other Identifier: UT MD Anderson Cancer Center )
NCI-T93-0088D
CDR0000078316 ( Registry Identifier: NCI PDQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Peter W. McLaughlin, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP