Brain and Central Nervous System TumorsPhase 2NCT00049361
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
A Phase 2 study testing temozolomide, thalidomide and radiation therapy in people with Brain and Central Nervous System Tumors and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 5 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy 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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- temozolomide, thalidomide and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- 1 Jan 2004to 7 Dec 2004
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed extracranial primary malignancy or brain metastases
- At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI
- No evidence of spinal drop metastases or spread to noncontiguous meninges
- No lymphoma, small cell lung cancer, or germ cell tumor
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 4 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin less than 1.5 mg/dL
- SGPT and/or SGOT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
- BUN no greater than 25 mg/dL
Other
- Able to be regularly followed
- No sensory neuropathy greater than grade 2
- No other major medical illnesses that would preclude study
- No neurologic or psychiatric impairments that would preclude study
- No active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No other concurrent chemotherapy during and for 4 weeks after study
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to head or neck
- No prior stereotactic radiosurgery
- Concurrent radiotherapy to extracranial sites of underlying malignancy allowed
Surgery
- Prior craniotomy allowed if completed within the past 10-28 days
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1030
About this study
Official title: A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
RATIONALE: Drugs used in chemotherapy 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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.
Read the detailed description
OBJECTIVES:
- Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.
- Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.
- Determine the cause of death of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.
Patients are followed at 1 and 3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.
- Being tested
- temozolomide, thalidomide, radiation therapy
- Keywords
- adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
thalidomideDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall median survival
Secondary outcomes (6)
Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter
Median time to tumor progression
Median time to neurologic response and progression
Cause of death at median time
Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start1 Jan 2004
- Primary completion7 Dec 2004
- Study completion7 Dec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Volker W. Stieber, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049361
- Sponsor's protocol ID
- REBACDR0000258057
- Other IDs
- CCCWFU-91102, NCI-5883
- Status last verified
- Sep 2021
- First submitted
- 12 Nov 2002
- Last updated
- 9 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases
- ClinicalTrials.gov ID
- NCT00049361
- Acronym / sponsor ID
- REBACDR0000258057
- Keywords
- adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 7 Dec 2004 (actual)
- Study completion
- 7 Dec 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy 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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.
Detailed description
OBJECTIVES:
- Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.
- Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.
- Determine the cause of death of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.
Patients are followed at 1 and 3 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temozolomide | Drug | – |
| thalidomide | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Overall median survival
6 secondary outcomes
Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter
Median time to tumor progression
Median time to neurologic response and progression
Cause of death at median time
Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker W. Stieber, MD study chair
Wake Forest University Health Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide, thalidomide and radiation therapy in people with Brain and Central Nervous System Tumors and Unspecified Adult Solid Tumor, Protocol Specific, run by Wake Forest University Health Sciences at 5 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall median survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2021.