Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

Study Overview
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Brief Summary
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RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.

Detailed Description
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OBJECTIVES: Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide. Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen. Determine the quantitative and qualitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Official Title
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Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage IV malignant melanoma Surgically incurable disease Measurable or evaluable disease No brain metastases by CT scan or MRI Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy Must have received 1, and only 1, prior systemic therapy for metastatic disease Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy PATIENT CHARACTERISTICS: Age: Adult Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 75,000/mm^3 Hepatic: SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study HIV negative No AIDS or HIV-1-associated complex No other serious illness No serious active infections No sensory neuropathy greater than grade 1 No prior seizures or concurrent potential risk factors for the development of seizures No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered No concurrent filgrastim (G-CSF) No other concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered No concurrent hormonal therapy No concurrent systemic steroids (including creams) Radiotherapy: See Disease Characteristics At least 21 days since prior radiotherapy and recovered Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression No concurrent radiotherapy Surgery: See Disease Characteristics At least 21 days since prior surgery for primary or metastatic disease and recovered No concurrent surgery Other: At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered No other concurrent therapy No other concurrent investigational drugs No concurrent immunosuppressive medications Concurrent antihistamines allowed if no alternative medication available

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interferon alfa|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma