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Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00026520
Collaborator
National Cancer Institute (NCI) (NIH)
94
Locations
53
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II
Study Start Date :
Nov 1, 2001
Actual Study Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Veterans Affairs Medical Center - Phoenix (Hayden) Phoenix Arizona United States 85012
    4 Veterans Affairs Medical Center - Tucson Tucson Arizona United States 85723
    5 Arizona Cancer Center Tucson Arizona United States 85724
    6 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    7 Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock Arkansas United States 72205
    8 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    9 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    10 Veterans Affairs Medical Center - West Los Angeles Los Angeles California United States 90073
    11 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    12 Veterans Affairs Outpatient Clinic - Martinez Martinez California United States 94553
    13 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    14 Chao Family Comprehensive Cancer Center Orange California United States 92868
    15 University of California Davis Medical Center Sacramento California United States 95817
    16 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    17 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    18 David Grant Medical Center Travis Air Force Base California United States 94535
    19 University of Colorado Cancer Center Denver Colorado United States 80010
    20 Veterans Affairs Medical Center - Denver Denver Colorado United States 80220
    21 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    22 Dwight David Eisenhower Army Medical Center Fort Gordon Georgia United States 30905-5650
    23 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    24 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    25 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    26 CCOP - Central Illinois Decatur Illinois United States 62526
    27 Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines Illinois United States 60141
    28 Loyola University Medical Center Maywood Illinois United States 60153
    29 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    30 CCOP - Wichita Wichita Kansas United States 67214-3882
    31 Veterans Affairs Medical Center - Wichita Wichita Kansas United States 67218
    32 Veterans Affairs Medical Center - Lexington Lexington Kentucky United States 40511-1093
    33 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    34 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    35 Tulane University School of Medicine New Orleans Louisiana United States 70112
    36 Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana United States 71130-3932
    37 Veterans Affairs Medical Center - Shreveport Shreveport Louisiana United States 71130
    38 Boston Medical Center Boston Massachusetts United States 02118
    39 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    40 Veterans Affairs Medical Center - Ann Arbor Ann Arbor Michigan United States 48105
    41 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    42 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    43 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    44 Veterans Affairs Medical Center - Detroit Detroit Michigan United States 48201-1932
    45 Henry Ford Hospital Detroit Michigan United States 48202
    46 Providence Hospital - Southfield Southfield Michigan United States 48075-9975
    47 CCOP - Duluth Duluth Minnesota United States 55805
    48 Veterans Affairs Medical Center - Biloxi Biloxi Mississippi United States 39531-2410
    49 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    50 Veterans Affairs Medical Center - Jackson Jackson Mississippi United States 39216
    51 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    52 Veterans Affairs Medical Center - Kansas City Kansas City Missouri United States 64128
    53 CCOP - Kansas City Kansas City Missouri United States 64131
    54 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    55 CCOP - St. Louis-Cape Girardeau Saint Louis Missouri United States 63141
    56 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    57 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    58 Veterans Affairs Medical Center - Albuquerque Albuquerque New Mexico United States 87108-5138
    59 MBCCOP - University of New Mexico HSC Albuquerque New Mexico United States 87131
    60 Veterans Affairs Medical Center - Albany Albany New York United States 12208
    61 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    62 University of Rochester Medical Center Rochester New York United States 14642
    63 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    64 Veterans Affairs Medical Center - Cincinnati Cincinnati Ohio United States 45220-2288
    65 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0502
    66 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    67 CCOP - Columbus Columbus Ohio United States 43206
    68 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    69 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
    70 CCOP - Dayton Kettering Ohio United States 45429
    71 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    72 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States 73104
    73 Veterans Affairs Medical Center - Oklahoma City Oklahoma City Oklahoma United States 73104
    74 Oregon Cancer Center Portland Oregon United States 97201-3098
    75 Veterans Affairs Medical Center - Portland Portland Oregon United States 97207
    76 CCOP - Columbia River Program Portland Oregon United States 97213
    77 Veterans Affairs Medical Center - Charleston Charleston South Carolina United States 29401-5799
    78 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    79 CCOP - Greenville Greenville South Carolina United States 29615
    80 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    81 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    82 University of Texas Medical Branch Galveston Texas United States 77555-0209
    83 Veterans Affairs Medical Center - Houston Houston Texas United States 77030
    84 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    85 Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio Texas United States 78284
    86 Veterans Affairs Medical Center - Temple Temple Texas United States 76504
    87 CCOP - Scott and White Hospital Temple Texas United States 76508
    88 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    89 Veterans Affairs Medical Center - Salt Lake City Salt Lake City Utah United States 84148
    90 CCOP - Virginia Mason Research Center Seattle Washington United States 98101
    91 Swedish Cancer Institute Seattle Washington United States 98104
    92 Veterans Affairs Medical Center - Seattle Seattle Washington United States 98108
    93 CCOP - Northwest Tacoma Washington United States 98405-0986
    94 Madigan Army Medical Center Tacoma Washington United States 98431-5000

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Laura F. Hutchins, MD, University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00026520
    Other Study ID Numbers:
    • CDR0000069046
    • SWOG-S0026
    First Posted:
    Jun 25, 2003
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    Apr 1, 2003
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Interferons
    Interferon-alpha
    Thalidomide

    Study Results

    No Results Posted as of Jun 24, 2013