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Phase 1
2 Years
N/A
Open (Enrolling)
Both
Fanconi's Anemia

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Trial Information


PROTOCOL OUTLINE:

This is a dose escalation study.

Patients receive amifostine IV over 3-5 minutes three times a week for three weeks.

Cohorts of 3 patients receive one of three dose levels of amifostine. The maximum tolerated
dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting
toxicity.

Patients are followed weekly for 3 weeks.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of Fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity
assays, or molecular testing

Bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one
of the following: hemoglobin less than 8 g/dL; absolute neutrophil count less than
1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g.,
exercise limitation from anemia or spontaneous bleeding from thrombocytopenia)

Evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone
marrow aspiration; clonality on bone marrow cytogenetic analysis OR morphological changes
on bone marrow aspirate

Refusal of or unsuccessful with prior conventional therapies

--Prior/Concurrent Therapy--

Biologic therapy: No prior bone marrow transplantation; no concurrent hematopoietic growth
factors

Endocrine therapy: No concurrent androgens

--Patient Characteristics--

Hepatic: Bilirubin no greater than 2 times normal AST no greater than 3 times normal ALT
no greater than 6 times normal

Renal: Creatinine no greater than 2 times normal

Other: No prior malignancy; no active bacterial, viral, or fungal infection requiring
therapy other than prophylaxis; not pregnant; negative pregnancy test

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

W. Nicholas Haining

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

Unspecified

Study ID:

199/15281

NCT ID:

NCT00006127

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Fanconi's Anemia
  • Fanconi's anemia
  • aplastic anemia
  • hematologic disorders
  • rare disease
  • Anemia
  • Fanconi Anemia
  • Fanconi Syndrome

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115