Eligibility Criteria

Seattle Cancer Care Alliance (SCCA)

Seattle Cancer Care Alliance (SCCA)

Protocols 1410 and 2485 are now closed.

Protocol 2212

Human Immunodeficiency Virus (HIV)-Specific Immune Reconstitution after Hematopoietic Cell Transplant for Treatment of Hematologic Malignancy in Patients Infected with HIV

Purpose

We are performing this study because some patients with HIV also have a serious blood disorder, which needs to be treated with HCT. The study will monitor patients given HCT so that we will learn whether there are serious problems due to the HIV. The purpose of the study is to find out what happens to the latent HIV reservoir in patients who have HIV and who are given HCT for treatment of their leukemia or lymphoma. This study will offer a unique chance to understand the effect of intensive chemo/radiotherapy, and in many cases allogeneic grafts, on clearance of latently infected resting CD4+ cells and reconstitution of HIV-specific immune responses.

Major eligibility criteria

  1. Patients with a hematologic malignancy treatable with HSCT, who:
    a. have been on HAART for at least one month, and
    b. have a HIV load <5000 copies/ml.
  2. Patients must be able to donate autologous peripheral blood stem cells or have an HLA-matched donor.
  3. Patients must be <66 years old for allogeneic HCT, or <76 years old for autologous HCT.
  4. Patients must not have poor health, such as liver disease, kidney disease, lung disease, heart disease, or active infections.

Contact

For more information, contact the Clinical Coordinator Office at the Seattle Cancer Care Alliance, (1-800-804-8824) and reference protocol number 2212.

Protocol 2673

A Clinical Trial of Gene-Modified Stem Cells to Generate HIV-Resistant Cells in Conjunction with Standard Chemotherapy for Treatment of Lymphoma in Patients with HIV Infection

Purpose

We would like to examine whether we can take a sample of cells from a patient, genetically modify them in a lab to make them HIV-resistant, and then safely return them to the patient. We are studying this therapy in patients with HIV infection and newly diagnosed lymphoma for whom chemotherapy with or without radiation has been recommended as the best way to treat their lymphoma. The genetically modified cells will be infused after completion of the last cycle of chemotherapy, or combination chemo/radiation, which will make room for the genetically modified cells to take hold, grow, and produce more HIV-resistant blood cells. If a small amount of genetically modified cells are accepted in the body, we can use chemotherapy drugs to increase their numbers, If we observe enough genetically modified cells, then we want to see if the patient can safely come off their Highly Active Antiretroviral Therapy (HAART) regimen without experiencing a viral rebound of HIV.

Major eligibility criteria

  1. HIV+ patients with previously untreated Non-Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma (HL) who:
    1. Have not finished their first line regimen of chemotherapy.
    2. If not started on chemotherapy, plan to proceed with standard first-line therapy for NHL or HL.
    3. Have a HIV viral load <50 copies/ml.
    4. Are on stable continuous antiretroviral treatment (defined as a multi-drug regimen) for at least 3 months prior to enrollment.
  2. Patients must be 18-66 years old, inclusive.
  3. Patients must not have poor health, such as liver disease, kidney disease, lung disease, heart disease, or active infections.

Contact

For more information, contact the Clinical Coordinator Office at the Seattle Cancer Care Alliance (1-800-804-8824) and reference protocol number 2673.