Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsored by:	ALZA
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003827

Purpose

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.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Drug: amifostine trihydrate Drug: cytarabine Drug: topotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine hydrochloride Amifostine Topotecan hydrochloride Topotecan Cytarabine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	25
Study Start Date:	January 1999

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003827

Locations

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

ALZA

Investigators

Study Chair:

Henry C. Fung, MD, FRCPE

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066982, CHNMC-IRB-98056, ALZA-CHNMC-IRB-98056, NCI-V99-1533
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003827 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Study placed in the following topic categories:

Antimetabolites
Radiation-Protective Agents
Immunologic Factors
Amifostine
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
Immunosuppressive Agents
Antiviral Agents

Refractory Anemia
Leukemia
Preleukemia
Anemia, Refractory
Neoplasm Metastasis
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Topotecan
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Radiation-Protective Agents
Antimetabolites, Antineoplastic
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia
Preleukemia
Pathologic Processes
Syndrome
Therapeutic Uses

Cytarabine
Disease
Neoplasms by Histologic Type
Amifostine
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Protective Agents
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Topotecan
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 02, 2009