LeukemiaPhase 2NCT00003827
Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
A Phase 2 study testing amifostine trihydrate, cytarabine and topotecan hydrochloride in people with Leukemia and Myelodysplastic Syndromes, run by ALZA 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 cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- amifostine trihydrate, cytarabine and topotecan hydrochloride
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to not given
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following:
- Bilineage cytopenia
- Unfavorable cytogenetic abnormalities
- Refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast)
- At least 0.5 on the International Prognostic Score System
- No chronic myelomonocytic leukemia
- No hypocellular myelodysplastic syndrome (marrow cellularity less than 30%)
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count less than 1,500/mm3
- Platelet count less than 100,000/mm3
- Hemoglobin less than 10 g/dL
Hepatic:
- ALT less than 5 times upper limit of normal
Renal:
- Creatinine no greater than 1.4 mg/dL
Cardiovascular:
- No congestive heart failure
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Must have right atrial catheter inserted
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior blood or bone marrow transplantations
Chemotherapy:
- No prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine)
- No prior topotecan
- No prior amifostine
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- At least 24 hours since prior antihypertensive medication prior to amifostine
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
About this study
Official title: Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
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 cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.
Read the detailed description
OBJECTIVES:
- Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.
- Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.
- Determine the duration of response and time to disease progression following this treatment regimen in these patients.
OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.
Patients are followed at least monthly for 2 years, then every 3-6 months until death.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- amifostine trihydrate, cytarabine, topotecan hydrochloride
- Keywords
- refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
cytarabineDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2003 (estimated)
- Study startJan 1999
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.
- 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
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALZA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry C. Fung, MD, FRCPE, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003827
- Sponsor's protocol ID
- CDR0000066982
- Other IDs
- CHNMC-IRB-98056, ALZA-CHNMC-IRB-98056, NCI-V99-1533
- Status last verified
- Jul 2007
- First submitted
- 1 Nov 1999
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
- ClinicalTrials.gov ID
- NCT00003827
- Acronym / sponsor ID
- CDR0000066982
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Keywords
- refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, childhood myelodysplastic syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ALZAIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- First posted
- 25 Sep 2003 (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 cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.
Detailed description
OBJECTIVES:
- Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.
- Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.
- Determine the duration of response and time to disease progression following this treatment regimen in these patients.
OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.
Patients are followed at least monthly for 2 years, then every 3-6 months until death.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| amifostine trihydrate | Drug | – |
| cytarabine | Drug | – |
| topotecan hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Henry C. Fung, MD, FRCPE study chair
City of Hope Medical Center
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 amifostine trihydrate, cytarabine and topotecan hydrochloride in people with Leukemia and Myelodysplastic Syndromes, run by ALZA 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: status not confirmed, as of the sponsor's last update on 4 Dec 2013. 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?
Results are not available in the source record.
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.
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 4 Dec 2013.