Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01769911

Genetically Modified Peripheral Blood Stem Cell Transplant in Treating Patients With HIV-Associated Non-Hodgkin or Hodgkin Lymphoma

AUTOLOGOUS TRANSPLANTATION AND STEM CELL BASED-GENE THERAPY FOR THE TREATMENT OF HIV-ASSOCIATED LYMPHOMA

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years – 66 Years
Healthy volunteers
Not accepted

Summary

This clinical trial studies genetically modified peripheral blood stem cell transplant in treating patients with HIV-associated non-Hodgkin or Hodgkin lymphoma. Giving chemotherapy before a peripheral stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. Laboratory-treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and feasibility of infusing gene-modified, human immunodeficiency virus (HIV)-protected hematopoietic stem cells (HSC) after high-dose chemotherapy for treatment of acquired immunodeficiency syndrome (AIDS)-related lymphoma. II. To determine the dose of carmustine (BCNU) in combination with O\^6-benzylguanine (O6BG) that results in selection in vivo of gene-modified HIV-resistant cells. III. To estimate the effect of HIV infection on the presence of HIV-resistant blood cells as measured by genetic marking for vector sequences before and after antiviral treatment interruption. SECONDARY OBJECTIVES: I. Evaluate the molecular and clonal composition of gene-modified cells after hematopoietic cell transplant (HCT). II. Evaluate the molecular and clonal composition of gene-modified cells after O6BG/BCNU. III. Determine the correlation of the level of O6-methylguanine- methyltransferase (MGMT) (P140K) marking with toxicity and response. IV. Characterize the toxicity associated with in vivo selection. V. Determine the efficacy of the procedure for treatment of lymphoma: defined as time to disease progression, progression-free survival, treatment-related mortality, time to neutrophil and platelet recovery, and incidence of infections. TERTIARY OBJECTIVES: I. Effect of procedure on the latent HIV reservoir. II. Effect of procedure on HIV-specific immune reconstitution. OUTLINE: CONDITIONING: Patients receive carmustine intravenously (IV) over 3 hours on day -7, cytarabine IV over 2 hours twice daily (BID) and etoposide IV over 2 hours BID on days -6 to -3, and melphalan IV over 30 minutes on day -2. TRANSPLANTATION: Patients receive an autologous PBSC infusion and/or infusion of autologous transduced hematopoietic cells on day 0. Beginning 28-120 days later, patients eligible for in vivo selection after detection of gene-marked cells receive O6-benzylguanine IV over 1 hour and carmustine IV over 3 hours on days 14, 28, and then monthly until completion of therapy. Patients achieving \> 10% gene marking and CD4 count of \>= 500 cells/uL receive up to 2 courses of structured treatment interruption without undergoing in vivo selection. After completion of study treatment, patients are followed up periodically for 15 years.

Conditions

Interventions

TypeNameDescription
DRUGcarmustineGiven IV
DRUGcytarabineGiven IV
DRUGmelphalanGiven IV
DRUGetoposideGiven IV
DRUGO6-benzylguanineGiven IV
PROCEDUREautologous hematopoietic stem cell transplantationUndergo transduced and/or non-transduced transplant
PROCEDUREperipheral blood stem cell transplantationUndergo transduced and/or non-transduced transplant
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2015-02-01
Primary completion
2019-02-01
First posted
2013-01-17
Last updated
2015-05-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01769911. Inclusion in this directory is not an endorsement.