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Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery Clinical research trials and Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery. Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery  Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
For Condition: Recurrent Melanoma,stage 3 melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , H. Lee Moffitt Cancer Center and Research Institute
Synopsis: 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.
Details: OBJECTIVES: I. Determine the effectiveness and toxicity of adjuvant radiotherapy given concurrently with interferon alfa to patients with stage III or recurrent melanoma. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldDeConti, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Additional Information:
Study ID Numbers: CDR0000067747; MCC-11543,MCC-IRB-4511,NCI-G00-1750
Study Start Date: July 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005615
Other Recurrent Melanoma Studies:
1. Vaccine Therapy Plus Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
2. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
3. Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
4. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
5. Biological Therapy in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
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