Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003661
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
1999-11-01
Brief Title:
Chemotherapy Radiation Therapy and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Children and Adults With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy
PURPOSE Phase II trial to study the effectiveness of chemotherapy radiation therapy and umbilical cord blood transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy radiation therapy and umbilical cord blood transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the rates of hematologic and immune reconstitution in pediatric patients with high risk hematologic malignancies in first remission or in second or subsequent remission and adult patients with acute lymphocytic leukemia ALL or acute nonlymphocytic leukemia ANLL in second or subsequent remission who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood UCB transplantation II Determine the incidence of graft-versus-host disease in this setting III Determine whether contamination of umbilical cord blood with maternal cells is a clinical problem in this setting IV Describe the incidence of leukemic relapse in these patients after UCB transplantation V Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients VI Determine specifically whether larger recipients greater than 40 kg 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 undergo a back-up bone marrow harvest prior to treatment Patients receive 9 fractions of total body irradiation TBI on days -9 to -5 followed by melphalan IV on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1 If TBI is not allowed busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5 On day 0 patients receive umbilical cord blood infusion Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months Patients are followed indefinitely for survival and late toxicity
PROJECTED ACCRUAL A minimum of 48 patients will be accrued into this study within 4 years
OUTLINE Patients undergo a back-up bone marrow harvest prior to treatment Patients receive 9 fractions of total body irradiation TBI on days -9 to -5 followed by melphalan IV on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1 If TBI is not allowed busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5 On day 0 patients receive umbilical cord blood infusion Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months Patients are followed indefinitely for survival and late toxicity
PROJECTED ACCRUAL A minimum of 48 patients will be accrued into this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-RP-9801 | OTHER | Roswell Park Cancer Institute | None |