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Combination Chemotherapy in Treating Patients With Intermediate-Grade or Immunoblastic Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002565
  Purpose

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. It is not yet known which combination chemotherapy regimen is more effective for intermediate-grade or immunoblastic non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have intermediate-grade or immunoblastic non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: bleomycin
Drug: cisplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: idarubicin
Drug: ifosfamide
Drug: mesna
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Phase III

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Mesna    Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Cyclophosphamide    Cytarabine    Cytarabine hydrochloride    Etoposide    Idarubicin    Idarubicin hydrochloride    Cisplatin    Methylprednisolone    Mitoxantrone hydrochloride    Mitoxantrone    Prednisone    Vincristine sulfate    Vincristine    Etoposide phosphate    Bleomycin    Bleomycin sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VS. CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   218
Study Start Date:   May 1994

Detailed Description:

OBJECTIVES: I. Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) vs. the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide). II. Compare the complete response rate achieved with ATT vs. standard CHOP. III. Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support. IV. Compare the predictive capability of the M.D. Anderson Tumor Score System vs. the International Index System.

OUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Arm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16. Arm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED.

PROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to this multicenter study. If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures, consideration will be given to early closure.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Previously untreated non-Hodgkin's lymphoma (NHL) of one of the following histologies: Diffuse large cell Follicular large non-cleaved cell Diffuse mixed cell Immunoblastic At least 2 of the following poor-prognosis factors required: Age over 60 Performance status greater than 1 Any elevation of LDH More than 1 extranodal site Ann Arbor stage III or IV T- and B-cell NHL eligible if meeting all above criteria No primary CNS lymphoma Brain involvement eligible if not primary

PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Any status Hematopoietic: (unless secondary to tumor) Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Elevation secondary to tumor discussed with study chairman Renal: (unless secondary to tumor) Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 55% by echocardiography Pulmonary: No chronic obstructive or restrictive lung disease Pulmonary consultation required in cases of doubt Other: No HIV infection No prior malignancy with less than a 90% 5-year survival probability No patients unable or unlikely to adhere to treatment because of geographic, economic, emotional, or social factors No unwillingness to accept blood product transfusions or other supportive measures (e.g., antibiotics)

PRIOR CONCURRENT THERAPY: No prior therapy

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002565

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030
Brazil
Faculdade de Medicina do ABC    
      Sao Paulo, Brazil, 01224--010
Chile
Clinica Alemana    
      Santiago, Chile, 5951

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Fernando Cabanillas, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000063574, MDA-DM-94017, NCI-T94-0040D
First Received:   November 1, 1999
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00002565
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I grade 3 follicular lymphoma  
stage I adult diffuse mixed cell lymphoma  
stage I adult diffuse large cell lymphoma  
stage I adult immunoblastic large cell lymphoma  
stage II grade 3 follicular lymphoma  
stage II adult diffuse mixed cell lymphoma  
stage II adult diffuse large cell lymphoma  
stage II adult immunoblastic large cell lymphoma  
stage III grade 3 follicular lymphoma  
stage III adult diffuse mixed cell lymphoma  
stage III adult diffuse large cell lymphoma  
stage III adult immunoblastic large cell lymphoma  
stage IV grade 3 follicular lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
contiguous stage II grade 3 follicular lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II grade 3 follicular lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma

Study placed in the following topic categories:
Prednisone
Methylprednisolone
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Prednisolone acetate
Cyclophosphamide
Etoposide phosphate
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Cisplatin
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Etoposide
Cytarabine
Methylprednisolone Hemisuccinate
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Methylprednisolone acetate
Vincristine
Bleomycin
Doxorubicin
Lymphatic Diseases
Ifosfamide
Idarubicin
Prednisolone
Mitoxantrone
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Mesna
Follicular lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Neuroprotective Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Alkylating Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Gastrointestinal Agents
Antimitotic Agents
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Autonomic Agents

ClinicalTrials.gov processed this record on September 16, 2008




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