Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003613 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: O6-benzylguanine Drug: carmustine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of O6Benzylguanine and BCNU in Cutaneous T-Cell Lymphoma |
Estimated Enrollment: | 20 |
Study Start Date: | January 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Kevin Cooper, MD | Case Comprehensive Cancer Center |
Investigator: | Stanton L. Gerson, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000066690, CASE-CWRU-6496, NCI-T97-0029, CASE-6496 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003613 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
Immunoproliferative Disorders Carmustine Sezary Syndrome Mycosis Fungoides Recurrence Lymphoma, Small Cleaved-cell, Diffuse Mycoses Lymphatic Diseases Cutaneous T-cell Lymphoma |
Lymphoma, T-Cell O(6)-benzylguanine Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Carmustine Enzyme Inhibitors Sezary Syndrome Mycosis Fungoides Pharmacologic Actions Lymphatic Diseases |
Neoplasms Therapeutic Uses Lymphoma, T-Cell O(6)-benzylguanine Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Alkylating Agents Lymphoma Lymphoma, T-Cell, Cutaneous |