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Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interferon alfa
Radiation therapy
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sylvester Cancer Center, University of Miami
  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interferon Alfa Plus Radiation

Arm Description

Combined Therapy: interferon alfa plus radiation therapy. 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Adverse Events
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.

Full Information

First Posted
May 2, 2000
Last Updated
September 21, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005615
Brief Title
Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining interferon alfa plus radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of interferon alfa plus radiation therapy in treating patients who have stage III or recurrent melanoma that has been removed by surgery.
Detailed Description
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 thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 2.75 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon Alfa Plus Radiation
Arm Type
Experimental
Arm Description
Combined Therapy: interferon alfa plus radiation therapy. 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.
Intervention Type
Biological
Intervention Name(s)
Interferon alfa
Intervention Description
Interferon alfa as outlined in treatment arm.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
Radiation therapy as outlined in treatment arm.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Objective response rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
Time Frame
Study Duration: 7 years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Review of adverse events utilizing Common Toxicity Criteria (CTC) V3.
Time Frame
Study Duration: 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald C. DeConti, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States

12. IPD Sharing Statement

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Post-Operative Adjuvant Radiotherapy With Concurrent Interferon-Alfa

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