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| Tracking Information | |||||||||||||||||||||
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| First Received Date ICMJE | December 10, 1999 | ||||||||||||||||||||
| Last Updated Date | July 23, 2008 | ||||||||||||||||||||
| Start Date ICMJE | August 1999 | ||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00004075 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery | ||||||||||||||||||||
| Official Title ICMJE | A Phase I Trial of 17-Allylaminogeldanamycin (17-AAG) in Solid Tumor and Lymphoma Patients | ||||||||||||||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with solid tumors that cannot be removed by surgery. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 treatment groups.
Cohorts of 1-6 solid tumor patients receive escalating doses of 17-AAG 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. Once the MTD is determined, 10 patients with either lymphoma or superficial solid tumors accessible for biopsy are treated as in group II at the MTD. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 58-130 patients (30-72 for group I and 28-58 for group II) 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 |
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| Intervention ICMJE | Drug: tanespimycin | ||||||||||||||||||||
| 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 | Completed | ||||||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||||||
| Completion Date | |||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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 | NCT00004075 | ||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||
| Study ID Numbers ICMJE | CDR0000067283, MAYO-990102, NCI-T99-0058 | ||||||||||||||||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||||||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
| Verification Date | September 2005 | ||||||||||||||||||||
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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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