Phase II Randomized Study of Dose-Intensive Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) with Filgrastim (G-CSF) Versus Dose-Intensive Prednisone, Doxorubicin, Cyclophosphamide, Etoposide, Cytarabine, Bleomycin, Vincristine, Mitoxantrone, and Leucovorin (ProMACE/CytaBOM) with G-CSF in Patients With Stage II, III, or IV Intermediate or High Grade non-Hodgkin's Lymphoma (Summary Last Modified 07/2000)
Basic Trial Information
|Phase II||Treatment||Closed||15 and over||NCI||SWOG-9349|
I. Compare the complete response rate, time to treatment failure, and overall survival of patients with stage II, III, or IV intermediate or high grade non-Hodgkin's lymphoma when treated with dose-intensive cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) with filgrastim (G-CSF) versus dose-intensive cyclophosphamide, doxorubicin, etoposide, prednisone, cytarabine, bleomycin, vincristine, methotrexate, and leucovorin (ProMACE/CytaBOM) with G-CSF. II. Assess the toxic effects and side effects associated with these regimens. III. Correlate clinicopathologic results with those from protocols SWOG-8819, SWOG-9245, and SWOG-8947 using the central serum and tissue repositories.
Biopsy-proven intermediate or high grade non-Hodgkin's lymphoma of one of the following histologic types (Working Formulation groups D through H and J): Follicular large cell Diffuse large cell Diffuse mixed cell Diffuse small cleaved cell Immunoblastic large cell Small noncleaved cell No lymphoblastic lymphoma No transformed lymphoma Pathology review of diagnostic specimen by SWOG Pathology Office required Biopsy section must be adequate to determine architectural pattern (bone marrow biopsy, needle aspirate, or needle biopsy is not sufficient) Bulky stage II and stage III/IV disease eligible (Ann Arbor criteria) Bulky disease defined as a mediastinal mass greater than one-third of the maximum chest diameter or any other mass at least 10 cm in maximum diameter No clinical or laboratory evidence of CNS involvement by lymphoma Bidimensionally measurable disease with clearly defined margins required Lesion at least 0.5 cm on medical photograph (skin or oral lesion) or plain x-ray (no bone lesions) Lesion on CT, MRI, or other imaging scan with both diameters greater than the distance between cuts of the imaging study Palpable lesion with both diameters at least 2 cm Bone marrow aspirate and biopsy required within 42 days of registration unless positive within the last 6 months CT of abdomen and pelvis required within 28 days prior to registration unless negative within 42 days prior to registration No prior diagnosis of lymphoma, Hodgkin's disease, myelodysplastic syndrome, or leukemia (even if disease-free for more than 5 years) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for lymphoma Prednisone or other corticosteroids are not considered chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified
Age: 15 and over Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine no greater than 2 times normal Creatinine clearance at least 60 mL/min Cardiovascular: No coronary artery disease, cardiomyopathy, congestive heart failure, or dysrhythmia requiring therapy Left ventricular ejection fraction normal by MUGA within 42 days prior to registration if cardiac history is questionable Pulmonary: DLCO greater than 50% Other: No known AIDS or ARC No second malignancy within 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of fertile patients
98 patients/arm will be accrued in approximately 18 months.
Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CTX Cyclophosphamide, NSC-26271 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 CF Leucovorin calcium, NSC-3590 MTX Methotrexate, NSC-740 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Arm I: 4-Drug Combination Chemotherapy with Hematopoietic Rescue. CHOP: CTX; VCR; DOX; PRED; with G-CSF. Arm II: 8-Drug Combination Chemotherapy with Hematopoietic Rescue. ProMACE/CytaBOM: CTX; DOX; VP-16; PRED; ARA-C; BLEO; VCR; MTX/CF; and G-CSF.
Blayney DW, LeBlanc ML, Grogan T, et al.: Dose-intense chemotherapy every 2 weeks with dose-intense cyclophosphamide, doxorubicin, vincristine, and prednisone may improve survival in intermediate- and high-grade lymphoma: a phase II study of the Southwest Oncology Group (SWOG 9349). J Clin Oncol 21 (13): 2466-73, 2003.[PUBMED Abstract]
Blayney DW, LeBlanc ML, Fisher RI, et al.: Dose-intense CHOPx2 therapy of intermediate grade lymphoma -- a phase II study of the Southwest Oncology Group (SWOG). [Abstract] Blood 98 (11 Pt 1): A-1448, 2001.
Trial Contact Information
Trial Lead Organizations
Southwest Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.