Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well amifostine works in treating young patients with newly diagnosed de novo myelodysplastic syndromes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of myelodysplastic syndromes (MDS)

• One of the following subtypes:

• Refractory anemia (RA)

• RA with ringed sideroblasts

• RA with excess blasts

• Refractory cytopenia with multilineage dysplasia (RCMD)

• RCMD and ringed sideroblasts

• MDS, unclassified

• MDS associated with isolated del 5(q)

• De novo disease

• No treatment-induced MDS

• No juvenile myelomonocytic leukemia

• No Down syndrome, Fanconi's anemia, or other inherited forms of hypoplastic bone marrow failure

PATIENT CHARACTERISTICS:

Age

• 1 to 21 at original diagnosis

Performance status

• Karnofsky 50-100% (patients > 16 years of age)

• Lansky 50-100% (patients 1 to 16 years of age)

Life expectancy

• At least 8 weeks

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT < 2.5 times ULN

Renal

• Radioisotope glomerular filtration rate ≥ 60 mL/min OR

• Creatinine clearance > 60 mL/min (based on Schwartz formula)

• Calcium normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Serum electrolytes normal

• Phosphorus normal

• Magnesium normal

• Glucose normal

• No other concurrent malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 8 weeks since prior growth factors

• No concurrent growth factors

• No concurrent hematopoietic stem cell transplantation

• No concurrent immunomodulating agents

Chemotherapy

• No prior amifostine

• No other concurrent anticancer chemotherapy

Endocrine therapy

• No concurrent daily steroid therapy

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No prior therapy for MDS