search
Back to results

Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cyclosporine
gemtuzumab ozogamicin
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate More than 20% blasts by morphologic criteria Relapsed disease ≥ 3 months after prior complete remission Blasts CD33-positive by flow cytometry No primary hematologic disorder that preceded initial presentation with AML No documented secondary AML related to prior chemotherapy or toxin exposure No acute promyelocytic leukemia (FAB M3) Not a candidate for transplant therapy No active CNS leukemia PATIENT CHARACTERISTICS: Age 60 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC ≤ 30,000/mm^3 (hydroxyurea allowed) Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 mg/dL Other HIV negative No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy Not planning hematopoietic stem cell transplantation immediately after study therapy Chemotherapy See Disease Characteristics See Hematopoietic Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 1 month since prior investigational agents No other concurrent anticancer therapy No administration of any of the following for 24 hours after cyclosporine administration: Diltiazem Verapamil Erythromycin Clarithromycin Metoclopramide Phenytoin Rifampin Phenobarbital Aminoglycosides Amphotericin B Vancomycin Cimetidine Ranitidine Trimethoprim/sulfamethoxazole Ketoconazole Fluconazole Itraconazole Voriconazole Carbamazepine

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Efficacy in terms of complete remission rate
Toxicity
Pharmacokinetics

Secondary Outcome Measures

Correlate clinical response to laboratory studies of drug susceptibility

Full Information

First Posted
August 4, 2004
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00089050
Brief Title
Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia
Official Title
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.
Detailed Description
OBJECTIVES: Primary Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia. Determine the toxicity and pharmacokinetics of this regimen in these patients. Secondary Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen. OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
gemtuzumab ozogamicin
Primary Outcome Measure Information:
Title
Efficacy in terms of complete remission rate
Title
Toxicity
Title
Pharmacokinetics
Secondary Outcome Measure Information:
Title
Correlate clinical response to laboratory studies of drug susceptibility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate More than 20% blasts by morphologic criteria Relapsed disease ≥ 3 months after prior complete remission Blasts CD33-positive by flow cytometry No primary hematologic disorder that preceded initial presentation with AML No documented secondary AML related to prior chemotherapy or toxin exposure No acute promyelocytic leukemia (FAB M3) Not a candidate for transplant therapy No active CNS leukemia PATIENT CHARACTERISTICS: Age 60 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC ≤ 30,000/mm^3 (hydroxyurea allowed) Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST or ALT ≤ 1.5 times ULN Renal Creatinine ≤ 1.5 mg/dL Other HIV negative No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy Not planning hematopoietic stem cell transplantation immediately after study therapy Chemotherapy See Disease Characteristics See Hematopoietic Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 1 month since prior investigational agents No other concurrent anticancer therapy No administration of any of the following for 24 hours after cyclosporine administration: Diltiazem Verapamil Erythromycin Clarithromycin Metoclopramide Phenytoin Rifampin Phenobarbital Aminoglycosides Amphotericin B Vancomycin Cimetidine Ranitidine Trimethoprim/sulfamethoxazole Ketoconazole Fluconazole Itraconazole Voriconazole Carbamazepine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen H. Petersdorf, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

We'll reach out to this number within 24 hrs