Busulfan, Etoposide, and Intensity-Modulated Radiation Therapy Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Myeloid Cancer

Summary

RATIONALE: Giving chemotherapy drugs, such as busulfan and etoposide, and intensity-modulated radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving intensity-modulated radiation therapy together with busulfan and etoposide before a transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy when given together with busulfan and etoposide followed by a donor stem cell transplant and to see how well it works in treating patients with advanced myeloid cancer.

Conditions

• 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)
• Blastic Phase Chronic Myelogenous Leukemia
• Childhood Acute Myeloid Leukemia in Remission
• Childhood Chronic Myelogenous Leukemia
• Childhood Myelodysplastic Syndromes
• Previously Treated Myelodysplastic Syndromes
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Refractory Anemia With Excess Blasts

Interventions

DRUG

busulfan

Given IV

DRUG

etoposide

Given IV

RADIATION

intensity-modulated radiation therapy

Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Stem cell transplantation occurs on Day 0 after High Dose Therapy

PROCEDURE

allogeneic bone marrow transplantation

Stem cell transplantation occurs on Day 0 after High Dose Therapy

PROCEDURE

peripheral blood stem cell transplantation

Stem cell transplantation occurs on Day 0 after High Dose Therapy

RADIATION

tomotherapy

Initially 150 cGy X 8 doses with gradual dose escalation to 200 cGy X 10 doses

Sponsors & Collaborators

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Anthony Stein · City of Hope Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

6 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-11

Primary Completion

2011-05-17

Completion

2011-08-09

Countries

• United States

Study Locations