Amifostine in Treating Patients With Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-06-05

Study Completion Date

2001-02-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Amifostine may improve blood counts in patients with myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of amifostine in treating patients with myelodysplastic syndrome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Amifostine With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome

NCT00003681

Anemia Myelodysplastic Syndromes

UNKNOWN PHASE2

Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome

NCT00005598

Myelodysplastic Syndromes

COMPLETED PHASE2

Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

NCT00003827

Leukemia Myelodysplastic Syndromes

UNKNOWN PHASE2

Amifostine & High-Dose Combination Chemotherapy in Treating Patients With Acute ML or CML

NCT00003407

Drug/Agent Toxicity by Tissue/Organ Leukemia Myelodysplastic Syndromes +1 more

WITHDRAWN PHASE2

Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00003268

Drug/Agent Toxicity by Tissue/Organ Leukemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES: I. Define the activity of amifostine in improving blood counts in patients with myelodysplastic syndrome.

OUTLINE: This is an open label, nonrandomized, single center, dose escalation study. Patients receive amifostine IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks. Responses are evaluated after each cycle (for a minimum of 2 induction cycles). Patients with a grade 0 toxicity in the first course receive a 25% increase in dose during the second course. Patients with grade 1 or 2 toxicity receive no dose change. Patients with grade 3 toxicity receive a 25% reduction in dose or treatment is stopped. All patients demonstrating response are eligible for maintenance therapy. Treatment is continued for up to 12 months or a total of 13 cycles.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amifostine

Amifostine IV 2 weeks, followed by 2 weeks rest (4 week cycle)

Group Type EXPERIMENTAL

Amifostine Trihydrate

Intervention Type DRUG

Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amifostine Trihydrate

Escalating dose IV for two weeks, followed by 2 weeks of rest. Each treatment cycle is 4 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ethyol Ethiofos Gammaphos

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 4 weeks of study and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No