Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Summary

This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.

Conditions

• Adult Acute Myeloid Leukemia in Remission
• Childhood Acute Lymphoblastic Leukemia in Remission
• Childhood Acute Myeloid Leukemia in Remission
• Childhood Myelodysplastic Syndrome
• Childhood Renal Cell Carcinoma
• Chronic Myelomonocytic Leukemia
• Clear Cell Renal Cell Carcinoma
• de Novo Myelodysplastic Syndrome
• Metastatic Renal Cell Cancer
• Previously Treated Myelodysplastic Syndrome
• Progression of Multiple Myeloma or Plasma Cell Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Adult Non-Hodgkin Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Recurrent Childhood Lymphoblastic Lymphoma
• Recurrent Childhood Non-Hodgkin Lymphoma
• Refractory Anemia
• Refractory Anemia With Ringed Sideroblasts
• Refractory Childhood Hodgkin Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Renal Medullary Carcinoma
• Type 1 Papillary Renal Cell Carcinoma
• Type 2 Papillary Renal Cell Carcinoma
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Adult Acute Myeloid Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

Fludarabine Phosphate

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo nonmyeloablative PBSCT

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo nonmyeloablative PBSCT

DRUG

Cyclosporine

Given PO

DRUG

Mycophenolate Mofetil

Given PO

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

2001-08-31

Primary Completion

2004-09-30

Completion

2004-09-05

Countries

• United States
• Germany
• Italy

Study Locations