Amifostine Plus Topotecan 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

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2002-11-30

Brief Summary

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

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

Related Clinical Trials

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

Phase I/II Study of Escalating-Dose Melphalan w/Autologous SCS & Amifostine Cytoprotect

NCT00003425

Breast Cancer Leukemia Lymphoma +4 more

COMPLETED PHASE1/PHASE2

Combination Chemotherapy Plus Amifostine in Treating Patients With Advanced Cancer

NCT00004036

Chronic Myeloproliferative Disorders Drug/Agent Toxicity by Tissue/Organ Leukemia +5 more

UNKNOWN PHASE1

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma

NCT00217438

Refractory Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma

COMPLETED PHASE3

Chemotherapy Given With Amifostine and Filgrastim in Treating Patients With Recurrent or Metastatic Cancer

NCT00003294

Leukemia Lymphoma Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer

NCT00002943

Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor +1 more

COMPLETED PHASE2

Detailed Description

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

OBJECTIVES: I. Evaluate the hematologic and cytogenetic response to treatment with amifostine plus topotecan in patients with myelodysplastic syndromes. II. Evaluate the toxic effects of this treatment in these patients. III. Evaluate the effects of this treatment on bone marrow recovery in these patients.

OUTLINE: This is a dose escalation study of topotecan. Patients receive amifostine IV followed by topotecan IV over 30 minutes on days 1-5 every 4-8 weeks for at least two courses. Patients who are responding after two courses of induction receive maintenance courses every 6-8 weeks for up to ten courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of topotecan. The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A maximum of 26 patients will be accrued for this study.

Conditions

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

Leukemia Myelodysplastic Syndromes

Study Design

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

Primary Study Purpose

TREATMENT

Interventions

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

amifostine trihydrate

Intervention Type DRUG

topotecan hydrochloride

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: See Disease Characteristics No hereditary hemolytic disorders Transferrin saturation greater than 20% Ferritin at least 50 ng/mL Hepatic: Bilirubin less than 3 mg/dL AST/ALT and LDH less than 2 times upper limit of normal Renal: Creatinine less than 2 mg/dL Cardiovascular: No significant cardiovascular disorders (unrelated to MDS) No uncontrolled hypertension Pulmonary: No significant pulmonary disorders (unrelated to MDS) Neurologic: No significant neurologic disorders (unrelated to MDS) No history of epilepsy Metabolic: No significant endocrine disorders (unrelated to MDS) Other: Not pregnant or nursing No significant gastrointestinal diseases (unrelated to MDS) or GI blood loss No significant genitourinary system diseases (unrelated to MDS) No active infection requiring IV antibiotic therapy No other serious illness or medical condition Not HIV positive Not hepatitis B surface antigen positive No iron, vitamin B12, or folate deficiencies No autoimmune disease No prior or concurrent malignancy within 2 years except in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic stimulants Chemotherapy: See Disease Characteristics At least 35 days since prior chemotherapy Endocrine therapy: No concurrent androgen therapy No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: At least 35 days since any previous therapy for MDS (other than transfusion) No participation in any other experimental clinical trial within 35 days of entry into current trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No