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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00068666
• Other study ID #: N0274
• Secondary ID: CDR0000327811NCI
• Status: Terminated
• Phase: Phase 2
• First received: September 10, 2003
• Last updated: December 14, 2016
• Start date: January 2004
• Est. completion date: March 2010

Study information

• Verified date: December 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: March 2010
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• temozolomide

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	McFarland Clinic, PC	Ames	Iowa
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Mercy Capitol Hospital	Des Moines	Iowa
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Hutchinson Area Health Care	Hutchinson	Minnesota
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Meeker County Memorial Hospital	Lichfield	Minnesota
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology Hematology, PA at Maplewood Cancer Center	Maplewood	Minnesota
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Hubert H. Humphrey Cancer Center at North Memorial Medical Center	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Saint Francis Cancer Center	Shakopee	Minnesota
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Medical X-Ray Center, PC	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	St. Joseph's Hospital	St Paul	Minnesota
United States	Park Nicollet Health Services	St. Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	St. Paul	Minnesota
United States	United Hospital	St. Paul	Minnesota
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Medical Oncology and Hematology Associates - West Des Moines	West Des Moines	Iowa
United States	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota
United States	Woodwinds Health Campus	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schild SE, Behl D, Markovic SN, Brown PD, Sande JR, Deming RL, Rowland KM Jr, Bearden JD. Brain metastases from melanoma: is there a role for concurrent temozolomide in addition to whole brain radiation therapy? Am J Clin Oncol. 2010 Dec;33(6):633-6. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed response rate		Up to 5 years	No
Secondary	Progression-free survival		Up to 5 years	No
Secondary	Overall survival		Up to 5 years	No
Secondary	Change in performance status		Up to 5 years	No