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Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes



Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes

For Condition: Dyskeratosis Congenita,Fanconi's Anemia,Thrombocytopenia,Shwachman syndrome
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , James Whitcomb Riley Hospital for Children
Synopsis: OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in patients with inherited bone marrow failure syndromes. II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF. III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before and after G-CSF using flow cytometry and immunohistochemistry.
Details: PROTOCOL OUTLINE: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously every day for 8 weeks; nonresponders receive an increased dose for an additional 8 weeks. Patients who respond at week 8 or 16 are then tapered to a lower maintenance dose of G-CSF administered every other day through week 40. The dose is adjusted to maintain an absolute neutrophil count above 1500. Patients are removed from study for failure to achieve a complete response by week 16, unacceptable nonhematologic toxicity, the identification of a clonal karyotype in marrow, or the onset of leukemia.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Inherited bone marrow failure syndrome, including: - Fanconi's anemia - Dyskeratosis congenita - Shwachman syndrome - Amegakaryocytic thrombocytopenia - Decreased megakaryocytes in infancy - No thrombocytopenia with absent radius syndrome (TAR) - No trisomy 13 or 18 - No clonal bone marrow karyotype --Prior/Concurrent Therapy-- - At least 4 weeks since growth factors - Concurrent therapy allowed if not altered for 30 days prior to entry through week 8 - No concurrent investigational drugs --Patient Characteristics-- - Hematopoietic: ANC <1000 - No leukemia - Other: No medical or psychiatric contraindication to protocol participation - No pregnant or nursing women
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
DavidWilliams,  Study Chair,  James Whitcomb Riley Hospital for Children


Additional Information:
Study ID Numbers:  199/11877;  UTMB-416
Study Start Date: December 1994
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004787

Other Thrombocytopenia Studies:
1. Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes

2. Study of Unrelated Allogeneic Bone Marrow Transplantation in Patients With Benign Congenital Bone Marrow Failure Disorders

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