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Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation


Phase 2
15 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

Phase II Study in Adults With Untreated Acute Lymphoblastic Leukemia Testing Increased Doses of Daunorubicin During Induction, and Cytarabine During Consolidation, Followed by High-Dose Methotrexate and Intrathecal Methotrexate in Place of Cranial Irradiation


OBJECTIVES:

- Determine the complete response rate and toxicity of escalating doses of daunorubicin
in patients under 60 years old with untreated acute lymphoblastic leukemia (ALL).

- Determine the complete response rate and toxicity of a constant dose of daunorubicin in
patients at least 60 years old with untreated ALL.

- Determine the toxicity of high dose cytarabine during postremission therapy in these
patients.

- Determine the CNS relapse rate of ALL when prophylactic intrathecal methotrexate and
high-dose intravenous chemotherapy replace cranial irradiation.

OUTLINE:

- Course I: Patients are assigned to 1 of 2 induction treatment groups based on age.

- Group 1 (under age 60): Patients receive cyclophosphamide IV over 15-30 minutes on
day 1, escalating doses of daunorubicin IV over 5-10 minutes on days 1-3,
vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-21,
asparaginase intramuscularly on days 5, 8, 11, 15, 18, and 22, and filgrastim
(G-CSF) subcutaneously (SC) beginning on day 4 and continuing for at least 7 days
and then until blood counts recover.

- Group 2 (age 60 and over): Patients receive vincristine, asparaginase,
cyclophosphamide, and G-CSF as in group 1, fixed dose daunorubicin IV over 5-10
minutes on days 1-3, and oral prednisone on days 1-7.

Patients are then evaluated for bone marrow cellularity on day 29. Those with M0, M1, or M2
cellularity proceed to course II. Patients with M3 cellularity may proceed to course II or
be removed from study.

- Course II (early intensification): Patients receive intrathecal methotrexate and
cyclophosphamide IV over 15-30 minutes on day 1, cytarabine IV over 3 hours on days
1-3, and G-CSF SC beginning on day 4.

Bone marrow is again examined on day 29. Patients with M0 or M1 cellularity after course I
and no sign of relapse after course II proceed to course III. Patients with M2 or M3
cellularity after course I must have M0 or M1 cellularity after course II to proceed to
course III. Patients with M2 or M3 cellularity after course II are removed from study.

- Course III: Patients receive intrathecal methotrexate, vincristine IV, and methotrexate
IV over 3 hours on days 1, 8, and 15 and oral methotrexate every 6 hours for 4 doses
beginning 6 hours after starting methotrexate IV on days 1, 2, 8, 9, 15, and 16.
Patients receive leucovorin calcium IV 6 hours after the last oral methotrexate dose on
days 2, 9, and 16 and oral leucovorin calcium beginning 12 hours after leucovorin
calcium IV for at least 4 doses on days 3, 4, 10, 11, 17, and 18.

Patients must be off leucovorin calcium for a minimum of 3 days before beginning days 8 and
15 of treatment. Patients who maintain M0 or M1 cellularity on day 29 of course III continue
therapy. Those with M2 or M3 cellularity after course III are removed from the study.

- Course IV (Late intensification): Repeat course I.

- Course V (Late intensification): Repeat course II.

- Course VI (CNS intensification): Repeat course III.

- Course VII (Prolonged maintenance): Patients receive oral mercaptopurine daily,
vincristine IV once every 4 weeks, oral prednisone on days 1-5, and oral methotrexate
on days 1, 8, 15, and 22. Courses repeat every 4 weeks for up to 18 months.

Patients with testicular disease receive gonadal radiotherapy anytime after course I.
Chemotherapy is not halted during radiotherapy.

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

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven acute lymphoblastic leukemia (FAB L1 or L2) or acute
undifferentiated leukemia

- Must be registered on companion protocol CALGB-9862

PATIENT CHARACTERISTICS:

Age

- 15 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior emergency leukapheresis allowed

- No other prior biologic therapy for leukemia

Chemotherapy

- Prior emergency treatment with hydroxyurea for hyperleukocytosis allowed

- No other prior chemotherapy for leukemia

- No other concurrent chemotherapy

Endocrine therapy

- No prior endocrine therapy for leukemia

- No concurrent hormonal therapy (except steroids for adrenal failure or hormones for
nondisease related conditions)

Radiotherapy

- One prior dose of cranial radiotherapy for CNS leukostasis allowed

- No other prior radiotherapy for leukemia

- No concurrent palliative radiotherapy except whole brain irradiation for CNS disease

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete Response

Outcome Time Frame:

6 months post treatment

Safety Issue:

No

Principal Investigator

Wendy Stock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000066807

NCT ID:

NCT00003700

Start Date:

January 1999

Completion Date:

January 2013

Related Keywords:

  • Leukemia
  • untreated adult acute lymphoblastic leukemia
  • L1 adult acute lymphoblastic leukemia
  • L2 adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
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 Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
St. Barnabas Medical CenterLivingston, New Jersey  07039
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
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Cooper Cancer InstituteCamden, New Jersey  08103