LeukemiaPhase 2NCT00002865
High-Intensity, Brief-Duration Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphocytic Leukemia
A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- filgrastim, cyclophosphamide and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1995to Aug 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN
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.
Read the 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.
- Conditions
- Leukemia
- Being tested
- filgrastim, cyclophosphamide, cytarabine, dexamethasone, doxorubicin hydrochloride
- Keywords
- recurrent adult acute lymphoblastic leukemia
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
cyclophosphamideDrug
cytarabineDrug
dexamethasoneDrug
etoposideDrug
ifosfamideDrug
mesnaDrug
methotrexateDrug
therapeutic hydrocortisoneDrug
low-LET cobalt-60 gamma ray therapyRadiation
low-LET photon therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy
Measured: 14 days
evaluate adverse events after brief, high intensity chemotherapy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2004 (estimated)
- Study startApr 1995
- Primary completionJun 2000
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bayard L. Powell, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002865
- Sponsor's protocol ID
- CDR0000065137
- Other IDs
- CCCWFU-21195, NCI-V96-1062
- Status last verified
- Aug 2018
- First submitted
- 1 Nov 1999
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIGH INTENSITY, BRIEF DURATION CHEMOTHERAPY FOR RELAPSED OR REFRACTORY ALL: A PHASE II STUDY OF A MULTIDRUG REGIMEN
- ClinicalTrials.gov ID
- NCT00002865
- Acronym / sponsor ID
- CDR0000065137
- Conditions
- Leukemia
- Keywords
- recurrent adult acute lymphoblastic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1995
- Primary completion
- Jun 2000 (actual)
- Study completion
- Aug 2001 (actual)
- First posted
- 11 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 outcome
response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy
Time frame: 14 days
evaluate adverse events after brief, high intensity chemotherapy
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayard L. Powell, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, cyclophosphamide and cytarabine in people with Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate for patients with relapsed or refractory acute lymphoblastic leukemia after brief, high intensity chemotherapy (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.