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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019318 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: romidepsin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Study Start Date: | August 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
| Study ID Numbers: | CDR0000065653, NCI-97-C-0135G, NCI-T95-0077 |
| Study First Received: | July 11, 2001 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019318 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma |
stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome |
|
Immunoproliferative Disorders Romidepsin Sezary Syndrome Mycosis Fungoides Recurrence Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Mycoses |
Lymphatic Diseases Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Romidepsin Antibiotics, Antineoplastic Lymphoproliferative Disorders Lymphoma Pharmacologic Actions |