Myelodysplastic SyndromesPhase 2NCT00003123
Amifostine in Treating Patients With Advanced Myelodysplastic Syndrome
A Phase 2 study testing amifostine trihydrate in people with Myelodysplastic Syndromes, run by Providence Hospital at 7 sites in United States.
Trial summary
RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome. PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- amifostine trihydrate
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 1997to 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven advanced myelodysplastic syndrome (MDS), including: Refractory anemia Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation MDS with at least bicytopenia No chronic myelomonocytic leukemia No acute leukemia
PATIENT CHARACTERISTICS: Age: 17 and over Performance Status: ECOG 0-2 Life Expectancy: Greater than 6 months Hematopoietic: Hemoglobin less than 8.5 g/dL Absolute granulocyte count less than 1,000 g/dL Platelet count less than 70,000/mm3 Hepatic: No major hepatic problems Renal: No major renal problems Cardiovascular: No major cardiac disease Other: Prior transfusion of blood products is allowed Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior cytokine therapy is allowed Chemotherapy: No prior chemotherapy Endocrine therapy: Prior steroid therapy is allowed Radiotherapy: Not specified Surgery: Not specified Other: Prior leucovorin calcium and pyridoxine allowed
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
Osteopathic Medical Oncology and Hematology, P.C.
Clinton Township, Michigan, 48038-1657
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Garden City Hospital
Garden City, Michigan, 48135
Marquette General Hospital
Marquette, Michigan, 49855
Providence Hospital Cancer Center
Southfield, Michigan, 48075
About this study
Official title: A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
RATIONALE: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.
Read the detailed description
OBJECTIVES: I. Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. II. Determine the toxic effects of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes three times a week. Patients failing to respond by 8 weeks undergo dose escalation. Nonresponding patients are removed from the study by 12 weeks. Therapy is continued for up to six months in responding patients. Patients are observed for duration of response upon therapy discontinuation. Patients who relapse will have therapy resumed at the previous dose. Patients will be followed until death.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- amifostine trihydrate
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation
- Medical subject headings
- Myelodysplastic Syndromes, Anemia, Refractory, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2004 (estimated)
- Study startAug 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Howard R. Terebelo, DO, Study chair, Providence Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003123
- Sponsor's protocol ID
- CDR0000065882
- Other IDs
- PH-890, ALZA-97-018-ii, NCI-V97-1350
- Status last verified
- Jan 2004
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Terebelo H, Marsico D, Shurafa M, et al.: A phase II trial of amifostine in patients with advanced myelodysplastic syndromes. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A82, 23a, 1999.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ethyol (Amifostine) in Adult Patients With Advanced Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00003123
- Acronym / sponsor ID
- CDR0000065882
- Conditions
- Myelodysplastic Syndromes
- Keywords
- refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Providence HospitalUniversity, hospital or other
- Study start
- Aug 1997
- First posted
- 12 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: Amifostine may be effective in helping blood counts return to normal in treating patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with advanced myelodysplastic syndrome.
Detailed description
OBJECTIVES: I. Determine the overall hematologic response rate to amifostine in patients with advanced myelodysplastic syndrome. II. Determine the toxic effects of amifostine in these patients.
OUTLINE: This is an open label study. Patients receive intravenous amifostine over 15 minutes three times a week. Patients failing to respond by 8 weeks undergo dose escalation. Nonresponding patients are removed from the study by 12 weeks. Therapy is continued for up to six months in responding patients. Patients are observed for duration of response upon therapy discontinuation. Patients who relapse will have therapy resumed at the previous dose. Patients will be followed until death.
PROJECTED ACCRUAL: A maximum of 36 patients will be accrued.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 17 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 | – |
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 6 Nov 2013.
- Results publicationTerebelo H, Marsico D, Shurafa M, et al.: A phase II trial of amifostine in patients with advanced myelodysplastic syndromes. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A82, 23a, 1999.
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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.
Howard R. Terebelo, DO study chair
Providence Hospital
7 sites 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 in people with Myelodysplastic Syndromes, run by Providence Hospital at 7 sites 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
On the ClinicalTrials.gov record for NCT00003123, which also lists 1 linked publication.
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 6 Nov 2013.