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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 CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Barnes-Jewish HospitalSaint Louis, Missouri  63110
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Oklahoma University Medical Center at University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73126
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401