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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Laura F. Hutchins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arkansas

Authority:

United States: Federal Government

Study ID:

CDR0000069046

NCT ID:

NCT00026520

Start Date:

November 2001

Completion Date:

April 2006

Related Keywords:

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
University of California Davis Medical CenterSacramento, California  95817
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - DuluthDuluth, Minnesota  55805
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Henry Ford HospitalDetroit, Michigan  48202
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
CCOP - GreenvilleGreenville, South Carolina  29615
University of Texas Medical BranchGalveston, Texas  77555-1329
Swedish Cancer InstituteSeattle, Washington  98104
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Dwight David Eisenhower Army Medical CenterFort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Boston Medical CenterBoston, Massachusetts  02118
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Rochester Medical CenterRochester, New York  14642
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Oklahoma Medical Research FoundationOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - Phoenix (Hayden)Phoenix, Arizona  85012
Oregon Cancer CenterPortland, Oregon  97201-3098