Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	16 and over	NCI	SWOG-8809

Objectives

I.  Compare the disease-free survival of patients with Stage III or IV 
low-grade non-Hodgkin's lymphoma randomly assigned to consolidation with 
interferon alpha vs. no consolidation therapy following intensive induction 
chemotherapy with ProMACE-MOPP 
(cyclophosphamide/doxorubicin/etoposide/prednisone/vincristine/nitrogen 
mustard/procarbazine/methotrexate plus leucovorin rescue) with or without 
radiotherapy.

II.  Determine the CR rate, duration of response, and survival of patients 
with low-grade non-Hodgkin's lymphoma treated with ProMACE-MOPP.

III.  Compare the toxicities of induction with ProMACE-MOPP (with or without 
radiotherapy) vs. induction followed by consolidation with interferon in this 
patient population.

Entry Criteria

Disease Characteristics:

Biopsy-proven low-grade non-Hodgkin's lymphoma:
  Diffuse, small, lymphocytic
  Follicular, predominantly small cleaved cell
  Follicular, mixed small cleaved and large cell

Measurable, clinical or pathologic Stage III/IV disease
required

  At a minimum, peripheral hemogram, liver function tests,
  chest x-ray, abdominal CT, and bone marrow biopsy required
  for staging

Chronic lymphocytic leukemia not eligible

No known CNS disease

Prior/Concurrent Therapy:

Biologic therapy:
  No prior biologic therapy

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Prior corticosteroid treatment allowed

Radiotherapy:
  No prior radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  16 and over

Performance status:
  SWOG 0-2

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Creatinine no more than 1.7 mg/dl
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  Normal cardiac function, i.e.:
     No history of severe heart disease
     No cardiomyopathy
     No CHF
     LVEF at least 50% by MUGA scan (only required if cardiac
     history is questionable)

Other:
  No prior malignancy that might recur and affect survival
  No AIDS or HIV-associated complex

Blood/body fluid analyses to determine eligibility and
imaging studies and physical exams for tumor measurement
completed within 14 days prior to registration; screening
exams other than blood/body fluid analyses and imaging
studies of nonmeasurable disease or uninvolved organs
completed within 42 days prior to registration

Repeat bone marrow exam required within 42 days of
registration if marrow exam negative 6 months prior to entry;
if marrow exam positive within 6 months prior to entry and no
interim treatment given, repeat marrow exam not required

Expected Enrollment

About 400 patients will have to be entered on Induction therapy in order to 
have the 252 patients required for randomization.  Accrual is anticipated to 
be complete in about 4 years.

Outline

All patients receive Induction chemotherapy on Regimen A, and those in PR with 
negative bone marrow after chemotherapy receive further Induction therapy with 
involved field irradiation on Regimen B; patients with PR and positive bone 
marrow receive additional chemotherapy, after which, if the marrow is negative 
and they are still in PR, they enter Regimen B.  All patients who achieve CR 
after treatment on either Regimen A or A and B and those patients with PR 
after treatment on Regimen B are randomized on Arms I and II.

Induction.

Regimen A:  8-Drug Combination Chemotherapy plus Leucovorin Rescue.  
ProMACE-MOPP:  Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; 
Etoposide, VP-16, NSC-141540; Mechlorethamine, Nitrogen Mustard, NM, NSC-762; 
Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, 
NSC-10023; Methotrexate, MTX, NSC-740; plus Leucovorin calcium, CF, NSC-3590.

Regimen B:  Radiotherapy.  Involved field irradiation using megavoltage 
equipment with minimum energies of Co60 or 2 MV x-rays.

Consolidation.

Arm I:  Biological Response Modifier Therapy.  Interferon alpha (Schering), 
IFN-A, NSC-377523.

Arm II:  No further treatment.

Fisher RI, Dana BW, LeBlanc M, et al.: Interferon alpha consolidation after intensive chemotherapy does not prolong the progression-free survival of patients with low-grade non-Hodgkin's lymphoma: results of the Southwest Oncology Group randomized phase III study 8809. J Clin Oncol 18 (10): 2010-6, 2000.[PUBMED Abstract]

Dana BW, Unger J, Fisher RI, et al.: A randomized study of alpha-interferon consolidation in patients with low-grade lymphoma who have responded to pro-mace-MOPP (DAY 1--8) (SWOG 8809). [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-10, 1998.

Hsi ED, Rimsza L, Goldman BH, et al.: MUM1 expression in follicular lymphoma is a poor prognostic marker in patients treated with immunochemotherapy (SWOG 9800/9911) but not chemotherapy alone (SWOG 8809): a Southwest Oncology Group correlative science study. [Abstract] Blood 112 (11): A-376, 2008.

Fisher RI, LeBlanc M, Press OW, et al.: New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol 23 (33): 8447-52, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Bruce Dana, MD, Protocol chair		Ph: 503-239-7767 Email: brucedana@usoncology.com