Viewing Study NCT00003243



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Study NCT ID: NCT00003243
Status: COMPLETED
Last Update Posted: 2010-03-10
First Post: 1999-11-01

Brief Title: Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Overview

Official Title: A Phase I Trial of Combined Chemotherapy and Donor Lymphocyte Infusion for Aggressive Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation
Status: COMPLETED
Status Verified Date: 2010-03
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 Combining more than one drug may kill more cancer cells White blood cells from donors may be able to kill cancer cells in patients who have hematologic cancer that has recurred following bone marrow transplantation

PURPOSE Phase I trial to study the effectiveness of combination chemotherapy plus infusion of donated white blood cells in treating patients who have hematologic cancer that has recurred after bone marrow transplantation
Detailed Description: OBJECTIVES

Determine the maximum tolerated dose of doxorubicin HCl liposome when combined with etoposide cyclophosphamide and allogeneic donor lymphocyte infusion with or without interleukin-2 after allogeneic bone marrow transplantation in patients with relapsed or persistent aggressive hematologic malignancies

OUTLINE This is a partially randomized dose-escalation study of doxorubicin HCl liposome LipoDox

Patients enter 1 of 4 cohorts

Cohort 1 Three to six patients receive induction comprising etoposide IV over 1 hour on days 1-3 cyclophosphamide IV over 1-2 hours on day 8 and allogeneic donor lymphocyte infusion on day 10 Filgrastim G-CSF is administered subcutaneously SC or IV daily beginning on day 10 and continuing until blood counts recover
Cohort 2 In the absence of dose-limiting toxicity DLT on cohort 1 3-6 patients receive treatment as in cohort 1 and LipoDox IV over 2 hours on day 1
Cohort 3 In the absence of DLT on cohort 2 3-6 patients are randomized to 1 of 2 treatment arms

Arm I Patients receive treatment as in cohort 1 plus a higher dose of LipoDox IV over 2 hours on day 1
Arm II Patients receive treatment as in cohort 1 and interleukin-2 IL-2 SC on days 10-12

If DLT is reached on cohort 2 3-6 patients receive treatment as in arm II

Cohort 4 In the absence of DLT on arms I and II patients receive treatment as in cohort 1 LipoDox as in arm I and IL-2 as in arm II

Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT

Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter

PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study within 12-18 months

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
NCI-V98-1387 US NIH GrantContract None httpsreporternihgovquickSearchP30CA006973
P30CA006973 NIH None None
JHOC-97112101 None None None