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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over		MSKCC-93163 NCI-V94-0466

Objectives

I.  Evaluate the safety and time to platelet engraftment of sequentially 
administered interleukin-3 and granulocyte colony stimulating factor (G-CSF) 
vs. G-CSF alone in patients with Hodgkin's disease or non-Hodgkin's lymphoma 
who have undergone autologous bone marrow transplantation.

Entry Criteria

Disease Characteristics:

Histologically confirmed Hodgkin's disease or non-Hodgkin's
lymphoma eligible for autologous bone marrow transplantation
(ABMT), i.e:
  Bone marrow of adequate cellularity (according to study
  site criteria) and free of tumor on biopsy obtained within
  4 weeks of harvest

  At least 1.0 x 10 to the eighth nucleated cells/kg obtained
  at harvest
     No marrow purging allowed

Prior/Concurrent Therapy:

At least 4 weeks since any investigational agent

Biologic therapy:
  No prior IL-3

  At least 2 weeks between marrow harvest or infusion and
  GM-CSF, G-CSF, PIXY321, or other hematopoietic growth
  factor

Chemotherapy:
  At least 4 weeks between marrow harvest and
  myelosuppressive chemotherapy (6 weeks since nitrosourea)

Endocrine therapy:
  No concurrent chronic systemic or prophylactically inhaled
  corticosteroids

Radiotherapy:
  No pelvic irradiation prior to marrow harvest

Surgery:
  Not specified

Other:
  No prior bone marrow transplantation
  No prior or concurrent peripheral blood progenitor cell
     support

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 60-100%

Life expectancy:
  At least 8 weeks

Hematopoietic:
  (obtained at bone marrow harvest)
  ANC at least 1,200
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 2.0 x ULN
  SGOT or SGPT no greater than 3.0 x ULN
  No active viral hepatitis
  No clinically significant hepatic dysfunction

Renal:
  Creatinine no greater than 2.0 mg/dl
  No clinically significant renal dysfunction

Cardiovascular:
  LVEF at least 40% on MUGA
  No history of thrombotic event (unless catheter-related):
     No acute MI
     No stroke
     No deep vein thrombosis
     No pulmonary embolism
  No clinically significant cardiovascular dysfunction

Pulmonary:
  FVC or FEV1 at least 50% of predicted
  DLCO at least 50% (corrected for hemoglobin)
  No clinically significant pulmonary dysfunction

Other:
  No HIV-positive test
  No history of active treatment for the following:
     Anaphylaxis
     Asthma
     Autoimmune disease
  No active infection requiring medical treatment
  No neurologic or other significant organ system dysfunction
     that would interfere with study drug evaluation
  No altered mental status or dementia that would preclude
     informed consent
  No second malignancy within 5 years that required active
  treatment except:
     Nonmelanomatous skin cancer
     In situ cervical cancer
  Negative urine or serum beta-HCG pregnancy test required of
     fertile women within 14 days of ABMT
  Effective contraception required of fertile patients

Expected Enrollment

A total of 76 patients will be entered at up to 12 participating institutions.

Outline

Randomized, double-blind study.  Patients are randomized prior to ABMT.  Study 
is double-blinded only from days 0 through 9.

The following acronyms are used:
  ABMT       Autologous Bone Marrow Transplantation
  G-CSF      Granulocyte colony stimulating factor (Amgen),                   
NSC-614629
  IL-3       Interleukin-3 (Sandoz), NSC-641115
  PLCB       Placebo

Arm I:  Hematopoietic Rescue.  IL-3; PLCB; G-CSF.

Arm II:  Hematopoietic Rescue.  G-CSF; PLCB.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Barrett H. Childs, MD, Protocol chair		Ph: 212-639-8682; 800-525-2225 Email: childsb@mskcc.org