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HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN


OBJECTIVES: I. Determine the complete response rate to high-intensity, brief-duration
chemotherapy with cyclophosphamide, methotrexate, vincristine, doxorubicin, and
dexamethasone followed by ifosfamide, methotrexate, vincristine, cytarabine, etoposide, and
dexamethasone in patients with relapsed or refractory acute lymphocytic leukemia (ALL). II.
Determine the toxic effects of these regimens in these patients.

OUTLINE: All patients receive up to six alternating courses (every 3-4 weeks) of two
chemotherapy regimens: cyclophosphamide, oral dexamethasone, methotrexate with leucovorin
rescue, vincristine, and doxorubicin over 5 days; and ifosfamide/mesna, oral dexamethasone,
methotrexate with leucovorin rescue, vincristine, cytarabine, and etoposide over 5 days.
G-CSF is given following each course until recovery of the neutrophil count. All patients
receive triple intrathecal chemotherapy on day 1. Patients with CNS disease receive
intrathecal therapy twice weekly until the CSF is clear, then weekly for 4 weeks, and
monthly for 1 year; those who have not received prior CNS irradiation also receive
whole-brain radiotherapy. Patients are followed monthly for 6 months, every 3 months for 18
months, every 6 months for 2 years, then annually.

PROJECTED ACCRUAL: A total of 37 evaluable patients will be accrued if at least 4 of the
first 17 patients respond.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia that is
relapsed after or refractory to induction therapy 1 or 2 prior inductions allowed, but
refractory to only 1 regimen CNS involvement allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-3 Hematopoietic: Not
specified Hepatic: Bilirubin no greater than 1.5 times normal (unless directly
attributable to leukemia) Renal: Creatinine no greater than 1.5 times normal (unless
directly attributable to leukemia) Cardiovascular: No uncontrolled or severe
cardiovascular disease including: Myocardial infarction within 6 months Congestive heart
failure Other: No uncontrolled duodenal ulcer No uncontrolled infection No second
malignancy within 5 years except curatively treated: In situ cervical cancer Basal cell
skin cancer No other serious medical illness that would limit survival to under 2 years No
psychiatric illness that would prevent informed consent or compliance No pregnant or
nursing women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: See Disease Characteristics

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:

response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Bayard L. Powell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000065137

NCT ID:

NCT00002865

Start Date:

April 1995

Completion Date:

August 2001

Related Keywords:

  • Leukemia
  • recurrent adult acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082