Deferasirox in Treating Patients With Iron Overload After Undergoing a Donor Stem Cell Transplant
Condition: Breast Cancer; Iron Overload; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Neuroblastoma; Ovarian Cancer
MeSH terms: Multiple Myeloma; Neuroblastoma; Neoplasms, Plasma Cell; Plasmacytoma; Myelodysplastic Syndromes; Iron Overload
Intervention: deferasirox
Intervention description: 20 mg/kg once daily orally for 6 months
Intervention MeSH terms: Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: iron overload

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.
    

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 = 1.6 mg/dL and creatinine
             clearance of > 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