Clinical Trial: Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.

PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.

Condition Treatment or Intervention Phase
childhood non-Hodgkin's lymphoma
Graft Versus Host Disease
Leukemia
Lymphoma
myelodysplastic and myeloproliferative diseases
 Drug: anti-thymocyte globulin
 Drug: busulfan
 Drug: cyclosporine
 Drug: melphalan
 Drug: methylprednisolone
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: radiation therapy
 Procedure: supportive care/therapy
 Procedure: umbilical cord blood transplantation
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients with High Risk Hematologic Malignancies

Further Study Details: 

OBJECTIVES:

  • Determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation.
  • Determine the incidence of graft-versus-host-disease in this setting.
  • Describe the incidence of recurrent disease in these patients post UCB transplant.
  • Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients.
  • Determine specifically whether larger recipients can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.

OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to treatment.

Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months.

Patients are followed at least monthly for 1 year, then every 6 months for the second year, and then annually thereafter.

PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4 years.

Eligibility

Ages Eligible for Study:  up to  54 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

Performance status:

  • Zubrod 0-1
  • Karnofsky 80-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without marrow involvement who elect to undergo autologous peripheral blood stem cell collection and storage:
  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • ALT/AST no greater than 4 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)

Pulmonary:

  • FVC and FEV_1 at least 60% of predicted for age
  • For adults:
  • DLCO at least 60% of predicted

Other:

  • HIV negative
  • No active infections at time of autologous stem cell harvest or pretransplant cytoreduction
  • Not pregnant or nursing
  • Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Location and Contact Information


Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-7284,  United States; Recruiting
Mary J. Laughlin, MD  216-368-5693    mjl13@po.cwru.edu 

Study chairs or principal investigators

Mary J. Laughlin, MD,  Study Chair,  Ireland Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066304; CWRU-4Y97; NCI-G98-1429; NCT00003335
Record last reviewed:  July 1999
Last Updated:  February 9, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003335
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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