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A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)


Phase 2
17 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

A Dose Escalation And Phase II Study Of Gemtuzumab Ozogamicin (CMA-676; Mylotarg) With High-Dose Cytarabine For Patients With Refractory Or Relapsed Acute Myeloid Leukemia (AML)


OBJECTIVES:

- Determine the response rate in patients with relapsed or refractory acute myeloid
leukemia treated with gemtuzumab ozogamicin (CMA-676) and high-dose cytarabine.

- Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of gemtuzumab ozogamicin (CMA-676) (phase I closed
to accrual effective 08/25/2003). Patients are stratified according to disease status
(refractory vs relapsed).

- Phase I (closed to accrual effective 08/25/2003): Patients are enrolled in one of four
cohorts.

- Cohort I (closed to accrual as of 10/1/02): Patients receive CMA-676 at the first
dose level IV over 2 hours on days 1 and 8.

- Cohort IA (open to accrual as of 10/15/02): Patients receive high-dose cytarabine
(HD-ARA-C) IV over 3 hours on days 1-5 and CMA-676 IV over 2 hours on day 7.

- Cohort II: Patients receive HD-ARA-C as in cohort IA and CMA-676 at the first dose
level IV over 2 hours on days 7 and 14.

- Cohort IV: Patients receive CMA-676 at the second dose level and HD-ARA-C as in
cohort II.

Dose escalation stops if at least 3 of 9 patients experience dose-limiting toxicity.

- Phase II: Patients receive HD-ARA-C IV over 3 hours on days 1-5 and CMA-676 IV over 2
hours on day 7 (one course).

Patients are followed at 1 month, monthly for 6 months, every 3 months for 2 years, and then
annually for 10 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study and a
total of 37 patients will be accrued for phase II of the study within 2 years. (Phase I
closed to accrual effective 08/25/2003).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Primary refractory acute myeloid leukemia (AML)

- More than 10% blasts in the bone marrow or blood after recovery from 2
courses of standard cytarabine- and anthracycline-based induction
chemotherapy

- No prior remission

- Relapsed AML

- More than 10% blasts in the bone marrow or blood after documented remission

- Prior remission lasted more than 30 days

- No prior treatment for current relapse

- CD33 expression on at least 20% of leukemia blast cells at initial diagnosis for
primary refractory patients or at the time of relapse for all other patients

- No active CNS involvement

PATIENT CHARACTERISTICS:

Age:

- 17 and over

Performance status:

- 0-2

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- WBC less than 30,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- No veno-occlusive disease of the liver

- No chronic liver disease unless due to AML

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active serious infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 6 months since prior stem cell transplantation

Chemotherapy:

- See Disease Characteristics

- Prior etoposide and/or thioguanine during remission induction allowed

- Prior hydroxyurea for control of AML allowed

- At least 24 hours since prior hydroxyurea

- At least 3 months since prior high-dose cytarabine (greater than 2
g/m^2/dose)-containing regimen

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent steroids for adrenal failure, hypersensitivity reactions, or septic shock
allowed

- Concurrent ophthalmic corticosteroids allowed

- Concurrent hormones for nondisease-related conditions (e.g., insulin for diabetes or
estrogens or progestins for gynecologic conditions) allowed

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- More than 2 months since prior cytotoxic therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission rate

Outcome Time Frame:

8 or 14 days after tx initiation & 30 d post tx

Safety Issue:

No

Principal Investigator

Richard M. Stone, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068208

NCT ID:

NCT00006265

Start Date:

March 2001

Completion Date:

May 2005

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Barnes-Jewish Hospital Saint Louis, Missouri  63110
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
University Hospital at State University of New York - Upstate Medical University Syracuse, New York  13210
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73126
Palm Beach Cancer Institute West Palm Beach, Florida  33401