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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 1, 1999 | ||||||||
| Last Updated Date | September 5, 2009 | ||||||||
| Start Date ICMJE | January 1999 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Alkylguanine-DNA alkyltransferase (AGT) modulation as measured by skin biopsy at baseline, 6 and 24 hours, and 1 week after the start of study treatment [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Alkylguanine-DNA alkyltransferase (AGT) modulation as measured by skin biopsy at baseline, 6 and 24 hours, and 1 week after the start of study treatment | ||||||||
| Change History | Complete list of historical versions of study NCT00003613 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | O(6)-Benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma | ||||||||
| Official Title ICMJE | Phase I Trial of O6Benzylguanine and BCNU in Cutaneous T-Cell Lymphoma | ||||||||
| Brief Summary | 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: This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE | Lymphoma | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Metabolic:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00003613 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000066690, CASE-CWRU-6496, NCI-T97-0029, CASE-6496 | ||||||||
| Study Sponsor ICMJE | Case Comprehensive Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | December 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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