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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	over 18 to 60	NCI	SUMC-26 NCI-T90-0124O, T90-0124

Objectives

I.  Determine whether peripheral blood mononuclear cells (PBMC) under the 
influence of granulocyte colony stimulating factor (G-CSF) can successfully 
engraft in Hodgkin's disease patients following high-dose chemotherapy with 
cisplatin/cytarabine/ dexamethasone, and determine whether this engraftment is 
sustained.
II.  Determine the number of aphereses necessary to collect 10 x 10 to the 
eighth mononuclear cells/kg.
III.  Determine the time to neutrophil and platelet recovery following therapy.
IV.  Compare the toxicities (e.g., mucositis, azotemia, hyperbilirubinemia) of 
G-CSF-mobilized PBMC rescue vs. autologous bone marrow therapy.
V.  Determine whether this regimen costs less than bone marrow transplant.

Entry Criteria

Disease Characteristics:

High-risk Hodgkin's disease, defined as:
  Recurrent disease following 1 or more regimens of
  combination chemotherapy (e.g., MOPP or ABVD)

Either bone marrow involvement or prior pelvic or other
irradiation precluding the use of fractionated TBI required

Measurable or evaluable disease required

No CNS involvement

Prior/Concurrent Therapy:

Prior therapy appropriate for the disease is allowed

At least 4 weeks since prior therapy

Biologic therapy:
  Not specified

Chemotherapy:
  Failed 1 or more combination regimens (e.g., MOPP or ABVD)
  No more than 300 mg/sqm doxorubicin

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 to 60

Performance status:
  Karnofsky 80-100%

Life expectancy:
  Not specified

Hematopoietic:
  WBC at least 2,500
  ANC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin less than 1.5 x normal

Renal:
  Creatinine less than 1.5 x normal

Cardiovascular:
  Ejection fraction greater than 50%
  No coronary artery disease

Pulmonary:
  DLCO at least 65% of predicted

Other:
  HIV antibody negative
  No active skin or autoimmune diseases
  No prior malignancy except:
     Curatively treated carcinoma in situ of the cervix
     Basal cell skin carcinoma
  No other life-threatening illness
  No pregnant women

Expected Enrollment

40 patients will be entered (20 per arm).  If 3 of the first 10 patients fail 
to reconstitute within 3 weeks of transplant, the study will be stopped.

Outline

Patients who have failed MOPP only begin treatment on Regimen A; those who 
have failed MOPP/ABVD begin treatment on Regimen B.  All other patients 
receive cytoreduction therapy on Regimen C.  Prior to the second course, 
patients are randomized on Arms I or II.  Patients then proceed to Regimen D.
Regimen A:  4-Drug Combination Chemotherapy.  ABVD:  Doxorubicin, DOX, 
NSC-123127; Bleomycin, BLEO, NSC-120566; Vinblastine, VBL, NSC-49842; 
Dacarbazine, DTIC, NSC-45388.
Regimen B:  6-Drug Combination Chemotherapy.  Stanford V:  Mechlorethamine, 
NM, NSC-762; DOX; BLEO; VBL; Etoposide, VP-16, NSC-141540; Vincristine, VCR, 
NSC-67574.
Regimen C:  3-Drug Combination Chemotherapy:  DHAP:  Cisplatin, CDDP, 
NSC-119875; Cytarabine, ARA-C, NSC-63878; Dexamethasone, DM, NSC-34521.
Arm I:  Peripheral Blood Mononuclear Cell (PBMC) Harvest Following 
Hematopoietic Stimulation.  Multiple leukaphereses following Granulocyte 
Colony Stimulating Factor, G-CSF, NSC-614629.
Arm II:  PBMC Harvest without Hematopoietic Stimulation.
Regimen D:  3-Drug Combination Myeloablative Chemotherapy with Urothelial 
Protection followed by Peripheral Stem Cell Rescue and Hematopoietic 
Stimulation.  Carmustine, BCNU, NSC-409962; VP-16, Cyclophosphamide, CTX, 
NSC-26271; with Mesna, NSC-113891; followed by infusion of PBMC; and G-CSF.

Trial Contact Information

Trial Lead Organizations

Stanford Cancer Center

Nelson Chao, MD, Protocol chair		Ph: 919-668-1010 Email: chao0002@mc.duke.edu