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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002865
Recruitment Status : Completed
First Posted : August 11, 2004
Last Update Posted : August 10, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: 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 Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 1995
Actual Primary Completion Date : June 2000
Actual Study Completion Date : August 2001

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002865

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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Study Chair: Bayard L. Powell, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00002865     History of Changes
Other Study ID Numbers: CDR0000065137
First Posted: August 11, 2004    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
recurrent adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating