deferasirox in treating patients with iron overload after undergoing a donor stem cell transplant

Conditions: Breast Cancer; Iron Overload; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Neuroblastoma; Ovarian Cancer

Summary: rationale: deferasirox may be effective in treating iron overload caused by blood transfusions in patients who have undergone donor stem cell transplant. purpose: this phase ii trial is studying the side effects and how well deferasirox works in treating patients with iron overload after donor stem cell transplant.

objectives: primary * to evaluate the safety of deferasirox given over 6 months in reducing liver iron concentration in patients with transfusional iron overload after undergoing allogeneic hematopoietic stem cell transplantation. secondary * to evaluate the efficacy of deferasirox in reducing liver iron overload in these patients. outline: this is a multicenter study. patients receive oral deferasirox once daily for 6 months in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed at 4 weeks.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of iron overload, defined as serum ferritin \> 1,000 ng/ml and liver iron concentration ≥ 5 mg iron/g on tissue proton transverse relaxation rates magnetic resonance imaging (mri) * underwent prior allogeneic hematopoietic stem cell transplantation (hsct) using either myeloablative or reduced-intensity conditioning at least 12 months ago * no evidence of relapse or progression of the primary disease for which allogeneic hsct was performed * patients who have become red-cell transfusion independent (i.e., no red cell transfusions within the past 3 months) as well as patients who require red cell transfusions are eligible * meets one of the following criteria: * ineligible for phlebotomy (hemoglobin \< 11 g/dl, poor intravenous access, or unable to undergo phlebotomy every 4 weeks) * have failed treatment with phlebotomy (serum ferritin \> 50% of baseline after 3 months of phlebotomy) * refused phlebotomy * ecog performance status of 0-2 * life expectancy ≥ 6 months * adequate renal function defined as serum creatinine \ or = 60 ml/min calculated using the crockcroft-gault formula on 2 occasions within 30 days of enrollment * sexually active men and women must use an effective method of contraception. alternatively, women must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal. * must be able to give written informed consent. * prior therapy with deferoxamine allowed provided it was completed ≥ 12 months ago exclusion criteria: * contraindication for performing mri or inability to undergo mri because of claustrophobia or weight (\>350 pounds). * inability to take medications orally. * uncontrolled bacterial, viral, or fungal infection * anc ≥ 1,000/mm³ * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 50,000/mm³ * aspartate aminotransferance (ast) and alanine aminotransferase (alt) ≤ 5 times the upper limit of normal * less than 4 weeks since prior and no concurrent systemic investigational drug * less than 7 days since prior and no concurrent topical investigational drug. concurrent non-investigational medications needed to treat concomitant medical conditions are allowed, with the exception of other chelating agents. concurrent growth factors such as epoetin alfa, darbepoetin alfa, filgrastim (g-csf), and sargramostim (gm-csf) allowed. concurrent irradiated packed red-cell and platelet transfusions allowed as clinically indicated. concurrent low-doses of vitamin c supplements (≤ 200 mg/day) allowed. * concurrent iron supplements or multivitamins with iron. * aluminum-containing antacid therapies may not be taken simultaneously with deferasirox, but may be taken 2 hours before or after administration of deferasirox * on dialysis or status post-renal transplantation * pregnant or nursing

Keywords: iron overload