NCT00003048

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 1997

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 1997

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2001

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

September 6, 2004

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Myelodysplastic Syndromes

Keywords

de novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesAmifostineEthyolEthiofosGammaphos

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Amifostine

    Responses are evaluated after each cycle (for a minimum of 2 induction cycles).

    After each 4 week cycle

Study Arms (1)

Amifostine

EXPERIMENTAL

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

Drug: Amifostine Trihydrate

Interventions

Amifostine TrihydrateDRUG

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

Also known as: Ethyol, Ethiofos, Gammaphos
Amifostine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven myelodysplastic syndrome Less than 30% blasts in bone marrow PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Zubrod 0-2 Karnofsky 60-100% ECOG 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No New York Heart Association Class IV disease No antihypertensive medication within 24 hours of amifostine administration Other: Not pregnant or nursing Effective contraceptive method must be used during study No medical illness No psychosis Eligible patients with an HLA compatible donor are referred to bone marrow transplantation 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Amifostine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur Compounds

Study Officials

  • Razelle Kurzrock, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 6, 2004

Study Start

June 5, 1997

Primary Completion

February 12, 2001

Study Completion

February 12, 2001

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)