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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 to 65	Pharmaceutical / Industry	AMGEN-SCF-950123 NCI-V96-0956

Objectives

I.  Compare the number of CD34+ cells/kg collected using granulocyte 
colony-stimulating factor (G-CSF) vs. G-CSF combined with recombinant 
humanized methionyl stem cell factor (SCF) for stem cell mobilization in 
heavily pretreated patients with non-Hodgkin's lymphoma or Hodgkin's disease.

II.  Compare the engraftment rates (assessed by recovery of neutrophils to at 
least 500 and platelets to at least 20,000) of peripheral blood progenitor 
cells mobilized by these two regimens and administered as hematopoietic 
support following high-dose myeloablative therapy.

III.  Assess the safety of SCF when administered with G-CSF prior to 
myeloablation.

Entry Criteria

Disease Characteristics:

Histologic or morphologic confirmation of lymphoma
  Non-Hodgkin's lymphoma patients
     In remission or with chemosensitive disease AND
     Eligible for peripheral blood progenitor cell transplantation

  Hodgkin's disease patients
     In first or second relapse following chemotherapy OR
     Advanced disease with a less than complete response to initial
        chemotherapy

Heavily pretreated patients, defined by any of the following:
  At least 2 cycles of any of the following drugs:
     Melphalan            Nitrosoureas (including carmustine)
     Nitrogen mustard     Procarbazine
  10 or more chemotherapy courses
  High-dose cytarabine (total dose 7 grams or more)
  Radiotherapy to the mediastinum, abdomen, or pelvis (excluding spot
     irradiation)

No bone marrow involvement on standard histopathologic examination of marrow
aspirate and iliac crest biopsy

No documented brain metastasis

Prior/Concurrent Therapy:

See Disease Characteristics
No prior bone marrow or peripheral blood progenitor cell transplant
At least 1 week since hematopoietic growth factors

Patient Characteristics:

Age:
  18-65

Performance status:
  Karnofsky 80%-100%

Life expectancy:
  At least 6 months

Hematopoietic:
  WBC less than 15,000 if granulocyte colony-stimulating factor support given
     during prior chemotherapy courses
  ANC at least 2,000
  Platelets at least 100,000
  Hemoglobin at least 9 g/dL

Hepatic:
  Bilirubin less than 2.0 mg/dL
  No high risk of veno-occlusive disease of the liver (e.g., AST/ALT greater
     than 3 times normal)

Renal:
  Creatinine less than 2.0 mg/dL

Cardiovascular:
  Left ventricular ejection fraction normal by MUGA
  No uncontrolled hypertension (i.e., diastolic higher than 115 mm Hg)
  No unstable angina
  No congestive heart failure (i.e., NYHA class III/IV status)
  No coronary angioplasty within 6 months
  No myocardial infarction within 6 months
  No uncontrolled atrial or ventricular cardiac arrhythmia

Pulmonary:
  FEV and FVC at least 60%

Immunologic:
  No seasonal or recurrent asthma within 10 years
  No asthmatic symptoms (e.g., wheezing) related to current respiratory tract
     infection
  No history of positive allergy tests (skin or recall antigen skin test) to
     insect venom
  No anaphylactoid reaction manifested by disseminated urticaria, laryngeal
     edema, and/or bronchospasm (drug allergy manifested solely by rash and/or
     urticaria allowed)
  No history of angioedema or recurrent urticaria
     Isolated episode of urticaria more than 3 years ago allowed
  No active infection or fever of 38.2 C or higher
     Fever due to B symptoms allowed
  No allergy to E. coli-derived products
  No documented HIV infection

Other:
  No poorly controlled diabetes
  No psychiatric, addictive, or other disorder that precludes informed consent
  No second malignancy within 5 years except:
     Surgically cured basal cell carcinoma
     In situ cervical cancer
  No pregnant or nursing women
     Negative pregnancy test required of fertile women
  Effective contraception required of fertile patients

Expected Enrollment

Up to 126 evaluable patients will be studied; if statistical significance is 
reached after the first 50 evaluable patients are studied, the study may be 
closed.  The duration of the study is expected to be 10-12 months.

Outline

Patients are randomized for progenitor cell mobilization regimen only. 

Patients are randomly assigned to progenitor cell mobilization using 
granulocyte colony-stimulating factor (G-CSF) or G-CSF with stem cell factor 
for 1-9 days or until completion of peripheral blood progenitor cells (PBPC) 
harvest.  Three to 14 days later, patients with adequate harvest receive 
myeloablative therapy followed by PBPC rescue.  Following therapy, patients 
receive G-CSF until blood counts recover.

The myeloablative regimen is chosen prior to entry and may consist of 
total-body irradiation plus high-dose etoposide and cyclophosphamide; 
high-dose busulfan, melphalan, and thiotepa; or high-dose etoposide, 
cyclophosphamide, and carmustine.

Patients may not receive any of the following during treatment:  other 
investigational agents, other hematopoietic growth factors, other cytotoxic 
drugs, other radiotherapy prior to platelet recovery, pentoxifylline, white 
blood cell transfusion, or (during mobilization/harvest) beta-adrenergic drugs.

Patients are followed at days 60 and 100 posttransplant, then annually.

Trial Contact Information

Trial Lead Organizations

Amgen Incorporated

Melody Wyres, MS, Protocol chair		Ph: 805-447-2440