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Completed

NCT Number: NCT00002865

High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high-intensity, brief-duration chemotherapy in treating patients with relapsed or refractory acute lymphocytic leukemia.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Cyclophosphamide

Drug

Cytarabine

Drug

Dexamethasone

Drug

Doxorubicin hydrochloride

Drug

etoposide

Drug

ifosfamide

Drug

leucovorin calcium

Drug

Mesna

Drug

methotrexate

Drug

therapeutic hydrocortisone

Drug

vincristine sulfate

Drug

low-LET cobalt-60 gamma ray therapy

Radiation

low-LET photon therapy

Radiation

Primary outcomes

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

    Time frame: 14 days

  2. evaluate adverse events after brief, high intensity chemotherapy

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2000
Study completion
2001
First posted
Aug 11, 2004
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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