Overview

Depsipeptide in Treating Patients With Solid Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Romidepsin
Criteria
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