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Sponsors and Collaborators: |
Institute of Cancer Research, United Kingdom National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00248521 |
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: alvespimycin hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Cancer Research UK Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of 17-Dimethylaminoethyl-Amino-17-Demethoxygeldanamycin (17-DMAG) Given as a Once Weekly Infusion in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 35 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study.
Patients receive 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 17-DMAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study within 12-18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
No symptomatic pulmonary disease requiring medication, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Institute of Cancer Research - Sutton | |
Sutton, England, United Kingdom, SM2 5NG | |
Royal Marsden - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
United Kingdom, Northern Ireland | |
Belfast City Hospital Trust Incorporating Belvoir Park Hospital | |
Belfast, Northern Ireland, United Kingdom, BT8 8JR |
Study Chair: | Ian R. Judson, MA, MD, FRCP | Institute of Cancer Research, United Kingdom |
Study ID Numbers: | CDR0000442402, ICR-PH1/102, NCI-6547 |
Study First Received: | November 3, 2005 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00248521 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |