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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | December 13, 2008 | ||||
| Start Date ICMJE | August 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00019318 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Depsipeptide in Treating Patients With Solid Tumors | ||||
| Official Title ICMJE | Phase I Trial of a Four Hour Infusion of Depsipeptide (NSC630176) Given on Days 1 and 5 of a 21 Day Cycle in Patients With Refractory Neoplasms | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists. |
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| Detailed Description | OBJECTIVES: I. Determine the toxic effects and the maximum tolerated dose (MTD) of depsipeptide in patients with incurable solid tumors (per 3/29/00 notification, only patients with cutaneous T-cell lymphoma are being accrued). II. Determine antineoplastic activity of depsipeptide in these patients. OUTLINE: This is a dose escalation, multicenter study. Patients receive depsipeptide IV over 4 hours on days 1 and 5. Treatment continues every 21 days in the absences of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of depsipeptide. If 2 of 6 patients experience dose-limiting toxicity at a given dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose level . PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for this study within 18-24 months. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: romidepsin | ||||
| 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: Histologically confirmed incurable solid tumor (per 3/29/00 notification, only patients with cutaneous T-cell lymphoma are being accrued) No known standard therapy for the disease that is potentially curative or definitely capable of extending life expectancy No CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 PT/PTT no greater than 1.1 times upper limit of normal (ULN) Hepatic: Bilirubin less than 1.5 ULN AST less than 3 times ULN Renal: Creatinine less than 1.5 times ULN Cardiovascular: Cardiogram must be performed within 1 month of protocol registration No class III/IV heart disease Ejection fraction of at least 45% by MUGA or Echo Other: HIV negative No recent weight loss of greater than 10% of average body weight Oral intake of at least 1,200 calories/day No uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent illness such as seizure disorder, uncontrolled hypertension, or myelodysplastic syndrome PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) No prior doxorubicin of a total dose greater than 360 mg/m2 Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiation therapy with depsipeptide No prior radiation to greater than 25% of bone marrow Surgery: At least 21 days since prior major surgery |
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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 | NCT00019318 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065653, NCI-97-C-0135G, NCI-T95-0077 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2001 | ||||
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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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