Peripheral Stem Cell Transplantation Followed By Infusion of White Blood Cells in Treating Patients With AIDS-Related Lymphoma

• Status: Withdrawn
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Donor peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells are rejected by the body's normal tissues. Treatment with donor white blood cells may prevent this from happening.

PURPOSE: Phase II trial to study the effectiveness of donor peripheral stem cell transplantation followed by infusions of donor white blood cells in treating patients who have AIDS-related lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Cyclosporine; Cyclosporins

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Hodgkin's disease or non-Hodgkin's lymphoma

• Failed to achieve a complete remission with initial therapy OR

• Relapsed after initial therapy

• HIV-1 seropositive by Western Blot

• Measurable or evaluable (e.g., pleural fluid involvement) disease

• No leptomeningeal or parenchymal CNS involvement or active CNS leukemia

• HLA-A, B, or DR antigen matched or 1 antigen mismatched related donor available

• CD4 cell count greater than 100/mm3 (initial 12 patients) OR greater than 50/mm3 (subsequent patients)*

• HIV RNA less than 110,000 copies/mL* NOTE: *Unless not receiving optimal anti-retroviral therapy as defined by current clinical standards

PATIENT CHARACTERISTICS:

Age:

• Physiologic 65 and under

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Estimated disease-free survival less than 1 year

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin no greater than 2 mg/dL

• Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)*

• SGOT or SGPT no greater than 3 times ULN*

• Hepatitis B surface antigen negative NOTE: *Unless receiving indinavir

Renal:

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No symptomatic congestive heart failure

• No angina pectoris

• No uncontrolled hypertension

• LVEF at least 45% by radionuclide ventriculography

Pulmonary:

• No severe chronic obstructive lung disease

• No symptomatic restrictive lung disease

• DLCO greater than 50% predicted

Other:

• No active uncontrolled infection

• No history of cytomegalovirus retinitis or pneumonitis, even if treated

• No other disease that would limit life expectancy

• No symptomatic leukoencephalopathy

• No neuropsychiatric abnormalities that would preclude transplantation

• Human T-cell lymphotrophic virus (HTLV-1) antibody negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 1 week since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent chronic suppressive therapy