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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 to 65 NCI CLB-9351 CALGB-9351

Objectives

I.  Estimate the overall response rate of dose-intensified CHOP 
(cyclophosphamide/doxorubicin/vincristine/prednisone) in adults with 
low-intermediate-risk, high-intermediate-risk, and high-risk non-Hodgkin's 
lymphoma.

II.  Determine whether high-dose CHOP with granulocyte colony stimulating 
factor can be administered with acceptable toxicity in these patients.

III.  Evaluate whether early restaging gallium scans can identify a subset of 
patients less likely to achieve a durable complete response with high-dose 
CHOP alone.

Entry Criteria

Disease Characteristics:

Histologically confirmed, Stage II/III/IV non-Hodgkin's lymphoma of one of the
following histologic types (International Working Formulation E-H):
  Diffuse small cleaved cell
  Diffuse mixed cell
  Diffuse large cell
  Large cell, immunoblastic

Low-intermediate-risk, high-intermediate-risk, or high-risk disease
(International Index) required, i.e., with 1, 2, or 3 of the following risk
factors, respectively:
  Elevated serum LDH
  Ann Arbor Stage III/IV disease
  Performance status 2

Bidimensionally measurable disease on physical exam, x-ray, CT, or MRI
required (sonogram alone not acceptable)
  Hepatic disease considered measurable in either of the following cases:
     Clearly defined mass greater than 3.5 cm on CT, MRI, or ultrasound and
     considered to represent lymphoma

     Histologically documented involvement and liver greater than 5 cm below
     the costal margin on quiet respiration

  The following are not considered measurable:
     Barium studies (e.g., barium enema)
     Ascites or pleural effusion
     Bony disease (lytic lesions should be followed)
     CNS lesions
     Bone marrow involvement

No CNS lymphoma

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Steroids administered for less than 72 hours for impending superior vena
  cava syndrome (or similar indication) allowed

Radiotherapy:
  No prior radiotherapy

Surgery:
  More than 2 weeks since major surgery

Patient Characteristics:

Age:
  18 to 65

Performance status:
  ECOG 0-2

Life expectancy:
  Greater than 1 year

Hematopoietic:
  (unless due to biopsy-documented bone marrow involvement)
  AGC at least 1,500
  Platelets at least 100,000
  Hb at least 9.0 g/dl

Hepatic:
  (unless due to biopsy-documented liver involvement)
  Bilirubin less than 1.5 x normal
  SGOT or SGPT less than 2.5 x normal
  Alkaline phosphatase less than 3 x normal
  No comorbid liver disease

Renal:
  Creatinine less than 1.5 mg/dl OR
  Creatinine clearance at least 60 ml/min

Cardiovascular:
  LVEF at least 50% by MUGA
  No known pericardial or cardiac disease, e.g.:
     No MI
     No CHF
     No clinically significant cardiac dysrhythmia

Pulmonary:
  No comorbid lung disease

Other:
  No active, invasive, or life-threatening fungal or viral infection
  No other uncontrolled infection
  HIV seronegative (testing required)
  HBsAg negative
  No concomitant malignancy except:
     In situ cancer of the cervix
     Basal cell skin cancer
  Effective contraception required of fertile patients

Pretherapy tests completed within 4 weeks prior to registration

Expected Enrollment

Fifty-nine patients will be entered over approximately 10 months to obtain 50 
evaluable patients.  If 5 or 7 toxic deaths are seen in the first 20 or 35 
patients, respectively, treatment will stop.

Outline

4-Drug Combination Chemotherapy with Hematopoietic Stimulation.  CHOP:  
Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; Vincristine, 
VCR, NSC-67574; Prednisone, PRED, NSC-10023; with Granulocyte Colony 
Stimulating Factor (Amgen), G-CSF, NSC-614629.

Peterson BA, Johnson J, Shipp MA, et al.: High dose CHOP: a phase II study of initial treatment in aggressive non-Hodgkin lymphoma. Cancer and Leukemia Group B 9351. Leuk Lymphoma 48 (5): 870-80, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Margaret Ann Shipp, MD, Protocol chair		Ph: 617-632-3874; 866-790-4500