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Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Melanoma, Recurrent Melanoma

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Trial Information

Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma


OBJECTIVES:

- Determine the objective clinical response rate in patients with metastatic cutaneous or
ocular melanoma treated with interferon beta.

- Determine the frequency and degree of apoptosis induction in patients treated with this
drug.

- Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma
(ocular vs cutaneous).

Patients receive interferon beta subcutaneously once daily in the absence of disease
progression or unacceptable toxicity.

Patients are followed within 3 days after completion of study treatment and then for
survival.

PROJECTED ACCRUAL: A total of 28-56 patients (14-28 per stratum) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- Cutaneous or ocular disease

- Measurable disease

- No active unstable CNS metastases by neurologic exam AND CT scan or MRI

- Irradiated and/or resected CNS lesions allowed if there is no evidence of
disease by head MRI or CT scan for > 6 months after surgery and/or radiotherapy

- Patients with cutaneous metastases and previously irradiated and/or resected CNS
metastases are eligible if the CNS metastases are controlled and do not require
dexamethasone

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1 (0-2 for patients with cutaneous metastases)

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count ≥ 1,200/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.5 g/dL

Hepatic

- Bilirubin ≤ 1.5 mg/dL

- AST ≤ 3.0 times normal

- Alkaline phosphatase ≤ 2.5 times normal (10 times normal if due to bone metastases)

- Hepatitis B surface antigen negative

Renal

- Creatinine ≤ 1.5 mg/dL

Cardiovascular

- No serious cardiac arrhythmia requiring treatment

- No congestive heart failure

- No angina pectoris

- No New York Heart Association class II-IV heart disease

- No other severe cardiovascular disease

Other

- HIV negative

- No other malignancy within the past 3 years except basal cell or squamous cell skin
cancer or carcinoma in situ of the uterine cervix

- No history of seizure disorder

- No severe psychiatric disorder

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 12 months since prior adjuvant interferon alfa-2 (IFNα-2) therapy

- More than 30 days since prior IFNα-2 therapy for metastatic disease (6 months for
patients with cutaneous metastases)

- No more than 1 prior systemic regimen (chemotherapy or biologic) for metastatic
disease (3 regimens for patients with cutaneous metastases)

Chemotherapy

- See Biologic therapy

- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- Concurrent replacement therapy with physiologic doses of corticosteroids allowed

- No concurrent dexamethasone or other steroidal antiemetics or
anti-inflammatories

- No other concurrent hormonal agents except steroids administered for preexisting
adrenal failure or hormones administered for non-disease-related conditions (e.g.,
insulin for diabetes)

Radiotherapy

- See Disease Characteristics

- More than 28 days since prior radiotherapy and recovered

- No concurrent palliative radiotherapy

Surgery

- See Disease Characteristics

- No prior organ allograft

- More than 28 days since prior major surgery requiring general anesthesia

Other

- More than 28 days since prior antibiotics for local or systemic infection

- No concurrent aspirin

- No concurrent barbiturates

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course

Safety Issue:

Yes

Principal Investigator

Ernest C. Borden, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CASE1604

NCT ID:

NCT00085306

Start Date:

April 2004

Completion Date:

October 2007

Related Keywords:

  • Stage IV Melanoma
  • Recurrent Melanoma
  • recurrent melanoma
  • stage IV melanoma
  • iris melanoma
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • Melanoma
  • Skin Neoplasms

Name

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195