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O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma Clinical research trials and O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma clinical trial. Human subjects frequently get the finest healthcare available for their O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma  O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
For Condition: stage 2 cutaneous T-cell lymphoma,stage 1 mycosis fungoides/Sezary syndrome,stage 1 cutaneous T-cell lymphoma,stage 2 mycosis fungoides/Sezary syndrome,recurrent cutaneous T-cell lymphoma,recurrent mycosis fungoides/Sezary syndrome
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine and carmustine in treating patients who have stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the kinetics of O6-alkylguanine DNA alkyltransferase depletion in skin lesions of patients with cutaneous T-cell lymphoma after treatment with O6-benzylguanine. - Determine the toxicity of low-dose topical carmustine when administered after O6-benzylguanine in these patients. OUTLINE: This is a dose-escalation study of carmustine. Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed for 6 weeks. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cutaneous T-cell lymphoma - Stage IA, IB, or IIA disease - Must be able to biopsy tumor - Must have failed 1 conventional treatment other than topical corticosteroids, including ultraviolet B light, psoralen ultraviolet light, topical mechlorethamine, electron beam, photophoresis, chemotherapy, or immunotherapy agents - No known CNS involvement or primary CNS malignancy PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Absolute neutrophil count greater than 2,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - SGOT normal - Prothrombin time normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 70 mL/min Metabolic: - Calcium and electrolytes normal - Glucose-controlled (diet and insulin) diabetes allowed Pulmonary: - DLCO greater than 80% (except patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as determined by the principal investigator) - No pulmonary disease Other: - No active infection - Not pregnant or nursing - Fertile patients must use effective contraception during and for two months after study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent hematopoietic growth factors Chemotherapy: - See Disease Characteristics - No prior nitrosoureas Endocrine therapy: - See Disease Characteristics Radiotherapy: - See Disease Characteristics Surgery: - Not specified Other: - At least 4 weeks since any prior therapy and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SethStevens, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Seth Stevens 216-844-5432
Additional Information:
Study ID Numbers: CDR0000066690; CWRU-6496,NCI-T97-0029
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003613
Other Stage 1 Mycosis Fungoides/sezary Syndrome Studies:
1. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
2. Music Therapy to Ease Pain and Emotional Distress in Patients With Hematologic Cancer Who Are Undergoing High-Dose Therapy and Stem Cell Transplantation
3. MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
4. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
5. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Related Studies:
Other stage 1 mycosis fungoides/Sezary syndrome Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
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