Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome

NCT00003827 | Unknown Phase 2

• 4 other identifiers: CDR0000066982CHNMC-IRB-98056ALZA-CHNMC-IRB-98056NCI-V99-1533
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.

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

Interventions

amifostine trihydrate DRUG

cytarabine DRUG

topotecan hydrochloride DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• ALZA: lead

Study Sites (1)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts

Interventions

Amifostine; Cytarabine; Topotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; Anemia

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids

Study Officials

• Henry C. Fung, MD, FRCPE

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 25, 2003
• Study Start: January 1, 1999
• Last Updated: December 4, 2013

Record last verified: 2007-07

Locations

US (1)