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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	12 and over		FHCRC-526.0 NCI-V94-0412

Objectives

I.  Evaluate the hematopoietic toxicity of zidovudine (ZDV) in patients 
undergoing allogeneic bone marrow transplantation for HIV-associated 
non-Hodgkin's lymphoma.

II.  Examine the effect of ZDV on donor hematopoietic/lymphoid cells in HIV-1 
seropositive patients who undergo transplantation.

III.  Assess immune reconstitution following transplantation.

Entry Criteria

Disease Characteristics:

HIV-associated non-Hodgkin's lymphoma at good risk for allogeneic bone marrow
transplant, i.e., either:
  In first remission, or
  Relapsed with limited disease

HIV-1 antibody-positive and one of the following:
  HIV-1 lymphocyte culture-positive
  P24 antigenemic
  Polymerase chain reaction (PCR) positive for DNA or RNA

HLA-identical related donor who is HIV-1 antibody and PCR seronegative
required
  No T-cell-depleted donor marrow

No visceral involvement with Kaposi's sarcoma (e.g., of lung, liver)

Absolute CD4+ T-cell lymphocyte count greater than 200 at time of initial
referral

No current or prior history of the following infections:
  Mycobacterium avium intracellular
  Toxoplasmosis
  Cryptococcoses
  Cytomegalovirus retinitis
  Cytomegalovirus pneumonitis
  Acyclovir-resistant Herpes simplex

No other current life-threatening infection that would preclude bone marrow
transplantation
  Re-evaluation allowed following resolution

Prior/Concurrent Therapy:

Antiviral therapy:
  No more than 90 days of prior ZDV therapy unless ID 50 in vitro sensitivity
  testing of HIV-1 isolate is less than 1 micromolar

Patient Characteristics:

Age:
  12 and over

Other:
  No abnormal neurocognitive findings
  No sensory/motor peripheral neuropathy
  No pregnant or nursing women
  Effective contraception required of fertile women

Expected Enrollment

10 patients will be entered; the study will be stopped and re-evaluated if any 
2 patients fail to engraft following ABMT or if 5 patients survive longer than 
12 months and are free of HIV-1 infection.

Outline

The following acronyms are used:
   ACV        Acyclovir
   ABMT       Allogeneic Bone Marrow Transplant
   CYSP       Cyclosporine, NSC-290193
   GVHD       Graft-versus-Host Disease
   MTX        Methotrexate, NSC-740
   TMP-SMX    Trimethoprim-Sulfamethoxazole
   ZDV        Zidovudine, NSC-602670

Antiretroviral Therapy.  ZDV.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Stan Riddell, MD, Protocol chair		Ph: 206-667-5249 Email: sriddell@fhcrc.org