Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer

Summary

RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or methylprednisolone may stop this from happening.

PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms
• Unusual Cancers of Childhood

Interventions

BIOLOGICAL

anti-thymocyte globulin

Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein.

BIOLOGICAL

filgrastim

Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.

DRUG

busulfan

Patients who take the drug PO, busulfan will be administered at 1 mg/kg/ dose given by mouth every 6 hours for 16 consecutive doses. Pediatric patients who receive busulfan IV continuous infusion will receive a dose of 3.0 mg/kg/IBW if under the age of 2.Pediatric patients over the age of 2 will receive busulfan at a dose of 0.8 mg/kg/dose.

DRUG

carmustine

300mg/m2 IV dissolved in 500 cc NS infused over 2 hours into right atrial catheter on day -6.

DRUG

cyclophosphamide

For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.

DRUG

cyclosporine

Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID. The infusion will vary from 2-24hr depending on the incidence of side-effects.

DRUG

cytarabine

400 mg/m2 dissolved in 200cc D5W and infused over 30 minutes into right atrial catheter on days -5, -4, -3, -2.

DRUG

etoposide

Etoposide administration 200 mg /m2 dissolved in 1 liter NS and infused over 2 hours into right atrial catheter. Infusion to begin after cytarabine administration on days -5, -4, -3, -2. Etoposide administration 50 mg/kg IV over 24 hours, divided into 3 doses. Dilute in normal saline at a concentration of 0.4 mg/ml (Observe for precipitation). Administered IV with continuous infusion over 24 hours. Diuretics may be given for fluid overload.

DRUG

fludarabine phosphate

Fludarabine administered at 30 mg/m2 IVPB infused over 30 minutes into right atrial catheter on days -4, -3, -2. Fludarabine administered at 40 mg/m2 IVPB infused over 30 into the right atrial catheter on days -5, -4, -3, and -2.

DRUG

melphalan

140 mg /m2 in concentration of 0.45 mg/ml of NS infused over 30 minutes into right atrial catheter on day -1.

DRUG

methotrexate

Administered on days +1, +3, and +7.

DRUG

methylprednisolone

Methyl-prednisolone is administered IV as a rapid infusion.

DRUG

mycophenolate mofetil

Mycophenolate may be used as a substitute for Methotrexate

DRUG

tacrolimus

A drug used to decrease the risk of graft versus host disease (GvHD).

PROCEDURE

peripheral blood stem cell transplantation

The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy. The stem cell infusion takes 1-6 hours.

PROCEDURE

umbilical cord blood transplantation

The patient will receive ATG to improve the changes of engraftment and decrease their risk of graft versus host disease. The patient may receive ATG 3 times during their transplant regimen on days -3 through days -1

RADIATION

radiation therapy

Radiation will be given to you 2 times a day for 3 or 4 days.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Richard Maziarz, MD · OHSU Knight Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-02-28

Primary Completion

2008-02-29

Completion

2008-03-31

Countries

• United States

Study Locations