• Disease response [ Designated as safety issue: No ]
• Progression-free and overall survival [ Designated as safety issue: No ]
• GVHD [ Designated as safety issue: Yes ]
• Infections [ Designated as safety issue: Yes ]

• Disease response
• Progression-free and overall survival
• GVHD
• Infections

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy or chemotherapy used to kill cancer cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells. Pentostatin, mycophenolate mofetil, and cyclosporine may also prevent this from happening.

PURPOSE: This phase I/II trial is studying the side effects of pentostatin and donor white blood cells and to see how well they work in preventing graft rejection in cancer patients who have undergone a donor stem cell transplantation.

OBJECTIVES:

Primary

• Determine the safety and efficacy of pentostatin and donor lymphocyte infusion, in terms of preventing graft rejection, in cancer patients with low or falling donor T-cell chimerism after nonmyeloablative allogeneic stem cell transplantation.

Secondary

• Determine the incidence of graft-vs-host disease in patients treated with this regimen.
• Determine the incidence of infections in patients treated with this regimen.
• Determine disease response in patients with persistent disease treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over a few seconds or 20-30 minutes on day -2 and donor lymphocytes IV over 15-30 minutes on day 0. Treatment may repeat once beginning at least 28 days later. Patients are evaluated once 20 patients have been treated. If this regimen is found to be ineffective, subsequent patients receive pentostatin and donor lymphocytes as before, as well as oral cyclosporine twice daily beginning on day -3 and continuing until day 56.

Patients also receive oral mycophenolate mofetil once daily beginning on day 0 and continuing until day 27.

Patients are followed monthly for 3 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

• Breast Cancer
• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases
• Neuroblastoma
• Ovarian Cancer
• Sarcoma
• Testicular Germ Cell Tumor

• Biological: therapeutic allogeneic lymphocytes
• Drug: cyclosporine
• Drug: mycophenolate mofetil
• Drug: pentostatin

DISEASE CHARACTERISTICS:

• Has undergone prior allogeneic stem cell transplantation for cancer

  • Received nonmyeloablative conditioning regimen comprising fludarabine/2-3 Gy total body irradiation or 2 Gy total body irradiation
  • Related or unrelated donor

• Low or falling donor CD3-positive T-cell peripheral blood chimerism on 2 separate consecutive evaluations at least 14 days apart as indicated by 1 of the following:

  • < 50% chimerism
  • ≥ 20% decrease in chimerism AND second evaluation demonstrates < 50% chimerism
• Persistent donor CD3-positive cells (≥ 5% by fluorescence in situ hybridization or variable number of tandem repeats assay)

• Evidence of disease allowed provided disease is persistent and stable compared to the status prior to transplantation

  • No relapsed or progressive disease after transplantation
• Original stem cell donor available for further stem cell donation

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• Under 75

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Karnofsky 50-100% (patients 17-74 years of age) OR
• Lansky 40-100% (patients 1-16 years of age)

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception

• No grade II-IV acute GVHD

  • No increase of GVHD by ≥ 1 grade while discontinuing immunosuppressive therapy or tapering steroids
• No extensive chronic GVHD
• No immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Steroids must be tapered to a dose ≤ 0.25 mg/kg/day within 1-2 weeks before donor lymphocyte infusion

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• Prior immunosuppressive therapy (other than steroids [e.g., cyclosporine or mycophenolate mofetil]) for graft-vs-host disease (GVHD) allowed provided therapy is discontinued 1 day before study entry
• No other concurrent immunosuppressive therapy