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Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma


OBJECTIVES:

Primary

- Determine the response rate in patients with unresectable stage III or stage IV
malignant melanoma treated with FR901228 (depsipeptide).

Secondary

- Determine the progression-free and overall survival of patients treated with this drug.

- Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of malignant melanoma meeting 1 of the following stage criteria:

- Unresectable stage III disease

- Stage IV disease

- The following melanoma types are allowed:

- Cutaneous

- Mucosal

- Ocular

- Unknown primary

- Measurable disease by physical examination or imaging studies

- Lesions on bone scan and positron-emission tomography are not considered
measurable

- Measurable disease must be outside a previously irradiated port

- Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy

- No active CNS metastases by brain CT scan or MRI (performed < 4 weeks before study
entry)

- Solitary CNS lesions treated with surgery or stereotactic radiosurgery/gamma
knife are allowed provided disease has been stable AND there is no evidence of
new CNS lesions within the past 3 months

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

Hepatic

- AST and/or ALT ≤ 2.5 times upper limit of normal

- Bilirubin normal

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- No history of coronary atherosclerotic heart disease

- No history of myocardial infarction

- No history of congestive heart failure

- EKG normal

- LVEF > 40% by MUGA

- QTc < 500 msec

- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or
ventricular fibrillation ≥ 3 beats in a row)

- Cardiac hypertrophy allowed

- No left ventricular hypertrophy by EKG

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Potassium ≥ 4.0 mmol/L

- Magnesium ≥ 2 mg/dL

- No nonmelanoma malignancy within the past 5 years except carcinoma in situ or
squamous cell or basal cell skin cancer

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to study drug

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since prior immunotherapy, including any of the following:

- Interferon

- Interleukin

- Sargramostim (GM-CSF)

- Vaccines

- No concurrent biologic agents except filgrastim (G-CSF)

Chemotherapy

- No prior FR901228 (depsipeptide)

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- Prior whole brain radiotherapy allowed

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- See Disease Characteristics

- No prior coronary artery bypass graft or stent

Other

- At least 5 half-lives since prior and no concurrent agents that may cause QTc
prolongation

- No other concurrent investigational agents

- No other concurrent antineoplastic agents

- No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g.,
sodium valproate)

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent hydrochlorothiazide

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

David H. Lawson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000415355

NCT ID:

NCT00104884

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • iris melanoma
  • recurrent intraocular melanoma
  • extraocular extension melanoma
  • ciliary body and choroid melanoma, medium/large size
  • Melanoma
  • Uveal Neoplasms

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