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The Florida Melanoma Trial: A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma: Study Site & Coordinating Center

Phase 1/Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

The Florida Melanoma Trial: A Phase I/II Trial of Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa in the Treatment of Advanced Stage III Melanoma: Study Site & Coordinating Center

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

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

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

Inclusion 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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Outcome Time Frame:

Study Duration: 7 years

Safety Issue:


Principal Investigator

Ronald C. DeConti, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

December 2005

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • recurrent melanoma
  • Melanoma



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Sylvester Cancer Center, University of Miami Miami, Florida  33136