Clincosm LogoSign in Get a demo

Temozolomide and Radiation Therapy in Treating Patients With Stage IV Malignant Melanoma With Measurable and Unresectable Cancer of the Central Nervous System

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Terminated
CT.gov ID
NCT00068666
Collaborator
National Cancer Institute (NCI) (NIH)
41
Enrollment
45
Locations
1
Arm
74
Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining temozolomide with radiation therapy may make the tumor cells more sensitive to radiation therapy and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with radiation therapy works in treating patients with stage IV malignant melanoma with measurable and unresectable cancer limited to the central nervous system.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Systemic Temozolomide Treatment Of Melanoma Present In The Central Nervous System
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Mar 1, 2005
Actual Study Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: radiation + temozolomide

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.

Drug: temozolomide

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

  1. Confirmed response rate [Up to 5 years]

Secondary Outcome Measures

  1. Progression-free survival [Up to 5 years]

  2. Overall survival [Up to 5 years]

  3. Change in performance status [Up to 5 years]

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 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%

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259-5499
2 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
3 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
4 McFarland Clinic, PC Ames Iowa United States 50010
5 Cedar Rapids Oncology Associates Cedar Rapids Iowa United States 52403
6 Mercy Capitol Hospital Des Moines Iowa United States 50307
7 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
8 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
9 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
10 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
11 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
12 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
13 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
14 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
15 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
16 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
17 Fairview Ridges Hospital Burnsville Minnesota United States 55337
18 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
19 Fairview Southdale Hospital Edina Minnesota United States 55435
20 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
21 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
22 Meeker County Memorial Hospital Lichfield Minnesota United States 55355
23 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
24 Minnesota Oncology Hematology, PA at Maplewood Cancer Center Maplewood Minnesota United States 55109
25 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
26 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
27 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422-2900
28 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
29 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
30 Saint Francis Cancer Center Shakopee Minnesota United States 55379
31 St. Joseph's Hospital St Paul Minnesota United States 55102
32 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
33 Regions Hospital Cancer Care Center St. Paul Minnesota United States 55101
34 United Hospital St. Paul Minnesota United States 55102
35 Ridgeview Medical Center Waconia Minnesota United States 55387
36 Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota United States 55125
37 Woodwinds Health Campus Woodbury Minnesota United States 55125
38 Grandview Hospital Dayton Ohio United States 45405
39 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
40 CCOP - Dayton Dayton Ohio United States 45429
41 Middletown Regional Hospital Middletown Ohio United States 45044
42 Rapid City Regional Hospital Rapid City South Dakota United States 57701
43 Avera Cancer Institute Sioux Falls South Dakota United States 57105
44 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
45 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Svetomir Markovic, MD, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00068666
Other Study ID Numbers:
  • N0274
  • CDR0000327811
  • NCI-2012-02554
First Posted:
Sep 11, 2003
Last Update Posted:
Dec 15, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
stage IV melanoma
recurrent melanoma
tumors metastatic to brain
Additional relevant MeSH terms:
Melanoma
Temozolomide

Study Results

No Results Posted as of Dec 15, 2016