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A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System


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

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Trial Information

A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System


OBJECTIVES:

Primary

- Determine the response rate in patients with stage IV malignant melanoma with
measurable and unresectable disease of the central nervous system treated with
temozolomide and radiotherapy.

Secondary

- Determine the safety of this regimen in these patients.

- Determine the survival of patients treated with this regimen.

- Determine the effect of this regimen on performance status and mental status of these
patients.

- Determine the response of extra-cranial disease in patients treated with this regimen.

OUTLINE: Patients receive concurrent chemoradiotherapy comprising whole brain radiotherapy
daily on days 1-5, 8-13, and 16-21 and oral temozolomide daily on days 1-5. Subsequent
treatment with temozolomide repeats every 4 weeks for up to 8 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 18-41 patients will be accrued for this study within 13-30
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV malignant melanoma with measurable and unresectable
disease limited to the central nervous system (CNS)

- Study entry within 14 days of diagnosis of brain metastases

- Recursive partitioning analysis class I or II

- Disease for which no known standard therapy exists that is potentially curative or
proven capable of extending life expectancy

- No meningeal carcinomatosis based on imaging studies or on positive results from CSF
analysis

- No evidence of metastatic disease outside of the CNS

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL

Hepatic

- AST no greater than 3 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 3 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent uncontrolled infection

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer treated with local resection only

- No prior allergy or intolerance to dacarbazine

- No hypersensitivity to temozolomide or any of its components

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior biologic therapy

- More than 4 weeks since prior immunotherapy

Chemotherapy

- No prior temozolomide

- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
and recovered

Endocrine therapy

- Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging

Radiotherapy

- More than 4 weeks since prior radiotherapy

- No prior radiotherapy to more than 15% of the bone marrow

- No prior radiotherapy to the head and neck area

- No prior radiosurgery

Surgery

- See Radiotherapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed response rate

Safety Issue:

No

Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000327811

NCT ID:

NCT00068666

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Metastatic Cancer
  • stage IV melanoma
  • recurrent melanoma
  • tumors metastatic to brain
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Central Nervous System Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - DaytonKettering, Ohio  45429
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Middletown Regional HospitalMiddletown, Ohio  45044
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
McFarland Clinic, PCAmes, Iowa  50010
Woodwinds Health CampusWoodbury, Minnesota  55125
Minnesota Oncology Hematology, PA at Maplewood Cancer CenterMaplewood, Minnesota  55109