Umbilical Cord Blood and Placental Blood Transplantation in Treating Patients With Hematologic Cancer or Aplastic Anemia
Study Details
Study Description
Brief Summary
RATIONALE: Umbilical cord blood or placental blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood and placental blood transplantation in treating patients who have hematologic cancer or aplastic anemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
Determine the response rate of patients with chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder treated with allogeneic umbilical cord and placental blood transplantation.
-
Determine the toxicity of this regimen in these patients.
-
Determine survival in these patients treated with this regimen.
-
Determine the incidence of graft-versus-host disease in these patients treated with this regimen.
OUTLINE: Patients receive a standard preparative regimen for their disease. Following the preparative regimen patients undergo umbilical cord blood stem cell transplantation on day 0.
Patients are followed every 1-2 weeks for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 4-5 years.
Study Design
Outcome Measures
Primary Outcome Measures
- Response rate []
- Toxicity []
- Survival []
- Incidence of graft-versus-host disease []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of chronic myeloid leukemia, acute leukemia, lymphoma, myeloma, myelodysplasia, aplastic anemia, Fanconi's anemia, histiocytosis, hereditary immunodeficiency, or storage disorder
-
Eligible for allogeneic bone marrow transplantation, but lacking a donor
-
Available donor umbilical cord blood that is mismatched on no more than 2 HLA loci
-
HIV negative
-
Hepatitis B surface antigen and hepatitis C negative
PATIENT CHARACTERISTICS:
Age:
- Under physiologic 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
-
Bilirubin less than 2 times normal
-
No severe hepatic disease
-
Hepatitis B surface antigen and hepatitis C negative
Renal:
- Creatinine less than 2 times normal
Other:
-
HIV negative
-
Not pregnant or nursing
-
No other serious medical or psychiatric illness that would preclude study compliance
-
No serious infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Herbert Irving Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: David G. Savage, MD, Herbert Irving Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068384
- CPMC-IRB-7934
- CPMC-CAMP-021
- NCI-G00-1899