Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT00961220
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CTCL stages IA-IIA by histopathology and immunohistochemistry in screening biopsies confirmed at Case Western Reserve University within 6 months of enrollment; biopsies may be performed at the site of collaborating institutions and shipped to University Hospitals of Cleveland-Case Western Reserve University (UHC-CWRU)
* Performance status Eastern Cooperative Oncology Group (ECOG) grade 0, 1, or 2
* Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emollition for at least 4 weeks, with the exception of topical corticosteroids, which may be used up to 2 weeks before the trial start date
* Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects
* White blood cell (WBC) at least 3.5 x10E9/L
* Absolute neutrophil count (ANC) at least 1.6 x10E9/L
* Platelets \> 100,000/ul
* Bilirubin \< 1.5 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT) within normal range
* Creatinine =\< 1.5 mg/dL
* Electrolytes normal
* Controlled (diet and insulin) diabetes is permitted
* Demonstration of clinically normal lung function based on history and physical examination; patients with clinical evidence of pulmonary disease as determined by the investigator should have baseline lung function tests performed with demonstration of diffusing capacity of the lung for carbon monoxide (DLCO) \>= 70%; a DLCO single breath, adjusted for hemoglobin, will be utilized; we will not use DLCO/alveolar volume (VA) for inclusion or exclusion in this study
* Patients must have cutaneous disease that is amenable to biopsy and must be willing to undergo several sequential biopsies
* Must have failed at least one conventional treatment for CTCL other than topical corticosteroids; this includes phototherapy, topical mechlorethamine, topical or oral bexarotene, radiation therapy, photopheresis, chemotherapy, and immunomodulatory agents such as interferon and other retinoids
Exclusion Criteria:
* Patients who have received prior treatment with topical or systemic BCNU or other nitrosoureas
* Patients with known central nervous system involvement or primary central nervous system (CNS) malignancies
* Patients with performance status ECOG grade 3 or 4
* Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception
* Patients with an active infection which requires hospitalization, or which may affect the patient?s safety if the patient was enrolled
* Patients with pulmonary disease as determined by history, physical examination, chest X-ray, or pulse oximetry with \< 70% predicted DLCO
* CTCL patients with stage IIB-IVB disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00961220
Study Brief:
Protocol Section:
NCT00961220