Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
This clinical trial studies the side effects and best dose of giving fludarabine and total-body irradiation (TBI) together followed by a donor stem cell transplant and cyclosporine and mycophenolate mofetil in treating human immunodeficiency virus (HIV)-positive patients with or without cancer. Giving low doses of chemotherapy, such as fludarabine, and TBI before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 75 Years |
| Eligibility |
Inclusion Criteria: - Patients with hematologic malignancy, lymphoma or other HIV-associated malignancy are eligible provided these criteria are met: - The malignancy is in complete remission or very good partial remission, defined as a significant reduction of disease with therapy and no evidence for continued tumor growth in the case of lymphoma or solid tumors - Highly active antiretroviral therapy (HAART) is initiated within one month of hematopoietic cell transplant - Viral load has decreased by >= 1.5 logs or viral load < 5000 copies/ml plasma on HAART therapy - CD4 count is allowed to be > 100 cells/ul - HIV infected patients without malignancy who have failed HAART are eligible provided that these criteria are met: - They have been treated with more than one regimen of HAART for a total of at least 6 months duration - The viral load is < 50 copies/ml plasma - The CD4 count < 100 cells/ul - DONOR: Human leukocyte antigen (HLA) genotypically/phenotypically identical donor; if more than one HLA-identical sibling is available, priority will be given to donors matched for cytomegalovirus (CMV) status, ABO titer, and sex - Peripheral blood stem cells will be collected from donors greater than 12 years of age - Bone marrow will be collected from donors less than 12 years of age - DONOR: HLA phenotypically identical unrelated donor; match grades allowed: - Match grade 1: Matched at allele level for HLA-A, B, C, DRB1, and DQB1 - Match grade 2.1: Single allele disparity for HLA-A, B, C, DRB1, and DQB1 Exclusion Criteria: - Positive serology for toxoplasma gondii on treatment or with evidence of active infection - Patients with other disease or organ dysfunction that would limit survival to less than 30 days - Patients with medical history of noncompliance with HAART or medical therapy - DONOR: Donors for whom medical or psychologic reasons would make donor procedure intolerable - DONOR: Marrow donors who have increased anesthetic risk - DONOR: Donors who are HIV positive - DONOR: Age > 75 years |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Death from regimen toxicity or opportunistic infection | Within the first 100 days | Yes | |
| Primary | Death from GVHD | Within the first 360 days | Yes | |
| Primary | Successful induction of mixed hematopoietic chimerism as assessed by the percentage of peripheral blood T cells that are of donor origin | Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor. | Up to day 80 | No |
| Secondary | Overall survival | Examined and presented descriptively. | Up to 1 year | No |
| Secondary | Progression of HIV | Examined and presented descriptively. | Within 1 year | No |
| Secondary | Reconstitution of HIV-specific immunity | Examined and presented descriptively. | Up to 1 year | No |
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