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Phase 2
16 Years
60 Years
Open (Enrolling)
Both
Skin Ulcers, Sickle Cell Anemia

Thank you

Trial Information


PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of
two treatment arms. Arm I: Patients receive arginine butyrate IV over 6-9 hours at night 5
days a week for 12 weeks, plus concurrent standard local therapy consisting of cleaning,
saline irrigation, and dressing changes as prescribed by each patient's physician. Patients
who experience progressive healing receive arginine butyrate 3-4 times a week. Arginine
butyrate treatment may be discontinued and reinstated following a single 2 week medical
complication.

Arm II: Patients receive standard local therapy only for 12 weeks. Patients randomized to
arm II may cross over to receive arginine butyrate if no or less than 25% healing is
observed after 12 weeks.

Patients whose ulcers have closed by at least 15% per course may receive 2 additional 8-week
courses of arginine butyrate therapy and are followed for 2 months after healing is
completed.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Significant sickle cell syndrome including HbSS, S-beta
thalassemia, and hemoglobin variants Lower extremity or ankle ulcer (or ulcers) present
for at least 6 months without healing --Prior/Concurrent Therapy-- Biologic therapy: No
chronic transfusion therapy Chemotherapy: No prior or concurrent cancer chemotherapy No
concurrent butyrate derivatives Prior treatment with hydroxyurea allowed if on a stable
dose for at least 1 year Endocrine therapy: No concurrent corticosteroid therapy
Radiotherapy: Not specified Surgery: Not specified Other: Must be treated with antibiotics
prior to entry for complicating cellulitis or secondary infections --Patient
Characteristics-- Age: 16-60 Performance status: Not specified Hematopoietic: Not
specified Hepatic: No hepatic compromise Transaminases no greater than 250 IU Renal: No
renal compromise Creatinine no greater than 1.2 mg/mL (adults) Creatinine no greater than
0.9 mg/mL (teenagers) Other: Not pregnant Fertile patients must use effective
contraception No poorly controlled seizure disorders No other secondary conditions that
might inhibit immune function

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Douglas V. Faller

Investigator Role:

Study Chair

Investigator Affiliation:

Boston University

Authority:

United States: Federal Government

Study ID:

199/13302

NCT ID:

NCT00004412

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Skin Ulcers
  • Sickle Cell Anemia
  • dermatologic disorders
  • genetic diseases and dysmorphic syndromes
  • hematologic disorders
  • rare disease
  • sickle cell anemia
  • skin ulcers
  • thalassemia major
  • Anemia
  • Anemia, Sickle Cell
  • Skin Ulcer
  • Ulcer

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Boston University School of MedicineBoston, Massachusetts  02118
University of Illinois College of MedicineChicago, Illinois  60612