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Melanoma (Skin)Phase 2NCT00068666

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

A Phase 2 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 45 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin), Metastatic Cancer
What is being tested?
temozolomide and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
45 sitesUnited States
Study dates
Jan 2004to Mar 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Grandview Hospital

    Dayton, Ohio, 45405

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Meeker County Memorial Hospital

    Lichfield, Minnesota, 55355

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Minnesota Oncology Hematology, PA at Maplewood Cancer Center

    Maplewood, Minnesota, 55109

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa, 50266

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota, 55125

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
temozolomide, radiation therapy
Keywords
stage IV melanoma, recurrent melanoma, tumors metastatic to brain
Medical subject headings
Melanoma, Neoplasm Metastasis, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00068666
Study groupRoleWhat they receive
radiation + temozolomideExperimentalPatients 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.
Receives: Drug: temozolomide; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed response rate

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Progression-free survival

    Measured: Up to 5 years

  2. Overall survival

    Measured: Up to 5 years

  3. Change in performance status

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2003 (estimated)
  2. Study startJan 2004
  3. Primary completionMar 2005
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00068666
Sponsor's protocol ID
N0274
Other IDs
CDR0000327811, NCI-2012-02554
Status last verified
Dec 2016
First submitted
10 Sep 2003
Last updated
15 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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: 10.1097/COC.0b013e3181c4c54b.

    PubMed 20042969

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed response rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00068666, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.

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