Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery

Basic Trial Information

Objectives

I.  Determine the effectiveness and toxicity of adjuvant radiotherapy given 
concurrently with interferon alfa to patients with stage III or recurrent 
melanoma.

Entry Criteria

Disease Characteristics:

Histologically proven primary melanoma with extensive regional node metastases
 (T1-4, N1, M0) OR

Primary melanoma with clinically apparent metastases confirmed by
 lymphadenectomy (T1-4, N1-2, M0) OR

Clinically detected relapse of melanoma in regional node basin, confirmed by
 lymphadenectomy after prior management of primary site (T1-4, N1-2, M0) OR

Recurrence of melanoma in a nodal basin previously resected OR

Nodal metastatic melanoma arising from unknown primary, confirmed by
 lymphadenectomy (Tx, N1-2, M0)

Adenopathy from neck, axilla, or groin basins must meet one of the following
 criteria:
  At least 4 positive nodes containing tumor
  Nodal metastases at least 3 cm in size
  Gross extracapsular extension of tumor
  Recurrence after prior lymphadenectomy

Completely resected disease

No distant metastases

Prior/Concurrent Therapy:

Biologic therapy:
 Prior vaccine therapy allowed
 No prior immunotherapy, interferon, interleukins, levamisole, or other
  biologic response modifiers

 
Chemotherapy:
 No prior chemotherapy, including infusion or perfusion therapy

Endocrine therapy:
 No concurrent systemic corticosteroids 

Radiotherapy:
 No prior radiotherapy to the proposed site(s) of study

Surgery:
 See Disease Characteristics

Other:
 No other medication or treatment regimen that would preclude study
 No concurrent immunosuppressive therapy
 

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-1

Life expectancy:
 At least 6 months

Hematopoietic:
 WBC at least 3,000/mm3
 Platelet count at least 125,000/mm3
 Hematocrit at least 33%

Hepatic:
 AST, LDH, alkaline phosphatase and bilirubin no greater than 2 times upper
  limit of normal 

Renal:
 Creatinine no greater than 1.8 mg/dL
 BUN no greater than 33 mg/dL

Cardiovascular:
 No congestive heart failure (New York Heart Association class III or IV heart
  disease)

Neurologic:
 No prior CNS demyelinating or inflammatory disease
 No prior hereditary or acquired peripheral neuropathy
 No organic brain syndrome, significant impairment of cognitive function, or  
  psychiatric disorder that would preclude study

Other:
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception during and for 18 months
  after study
 No hypersensitivity to interferon alfa or any component of the injection
 No history of diabetes mellitus prone to ketoacidosis
 No uncontrolled thyroid abnormalities
 No clinically significant retinal abnormalities
 No other significant medical or surgical condition that would preclude study
 No prior invasive melanoma
 No other prior or concurrent malignancies within the past 5 years except any
  in situ cancer, atypical melanocytic hyperplasia, or basal or squamous skin
  cancer 
 No autoimmune disorders or immunosuppressive conditions  

Expected Enrollment

A total of 50 patients will be accrued for this study within 2.75 years.

Outline

This is a multicenter study.

Patients receive interferon alfa IV over 20 minutes daily for 5 consecutive 
days a week for 4 weeks.  Patients then receive radiotherapy on days 2 and 4 
and interferon alfa subcutaneously (SQ) on days 1, 3, and 5 for 2.5 weeks.  
Interferon alfa SQ continues 3 times a week for 10 months in the absence of 
disease progression or unacceptable toxicity.

Patients are followed every month for 3 months, then every 3 months for 2 
years, then every six months until year 5, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Ronald DeConti, MD, Protocol chair		Ph: 813-745-8466; 888-663-3488

Registry Information
Official Title		A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy with Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma
Trial Start Date		2000-07-25
Registered in ClinicalTrials.gov		NCT00005615
Date Submitted to PDQ		2000-03-07
Information Last Verified		2001-10-01
NCI Grant/Contract Number		P30-CA76292

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