Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Summary

This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor stem cell transplant in treating patients with hematologic malignancies or kidney cancer. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Acute Myeloid Leukemia in Remission
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• B-cell Chronic Lymphocytic Leukemia
• Childhood Acute Lymphoblastic Leukemia in Remission
• Childhood Acute Myeloid Leukemia in Remission
• Childhood Chronic Myelogenous Leukemia
• Childhood Myelodysplastic Syndromes
• Childhood Renal Cell Carcinoma
• Chronic Phase Chronic Myelogenous Leukemia
• Clear Cell Renal Cell Carcinoma
• de Novo Myelodysplastic Syndromes
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Nodal Marginal Zone B-cell Lymphoma
• Previously Treated Myelodysplastic Syndromes
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Recurrent Small Lymphocytic Lymphoma
• Recurrent/Refractory Childhood Hodgkin Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Hairy Cell Leukemia
• Refractory Multiple Myeloma
• Relapsing Chronic Myelogenous Leukemia
• Splenic Marginal Zone Lymphoma
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer
• T-cell Large Granular Lymphocyte Leukemia
• Type 1 Papillary Renal Cell Carcinoma
• Type 2 Papillary Renal Cell Carcinoma
• Waldenström Macroglobulinemia

Interventions

DRUG

fludarabine phosphate

Given IV

RADIATION

total-body irradiation

Undergo low-dose TBI

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo nonmyeloablative HSCT

PROCEDURE

allogeneic bone marrow transplantation

Undergo nonmyeloablative allogeneic bone marrow transplantation

PROCEDURE

peripheral blood stem cell transplantation

Undergo nonmyeloablative allogeneic PBSC transplantation

BIOLOGICAL

therapeutic allogeneic lymphocytes

Undergo DLI

DRUG

cyclosporine

Given PO

DRUG

mycophenolate mofetil

Given PO

OTHER

pharmacological study

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Brenda Sandmaier · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-11-30

Primary Completion

2002-07-31

Countries

• United States
• Germany

Study Locations