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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan E. Bates, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000065653

NCT ID:

NCT00019318

Start Date:

August 1997

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma

Name

Location

Medicine BranchBethesda, Maryland  20892