Metastatic CancerPhase 2NCT00012116
Temozolomide in Treating Patients With Solid Tumors That Have Spread to the Brain
A Phase 2 study testing temozolomide in people with Metastatic Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Apr 2002
- 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
Who may be able to join
- Age greater than or equal to 18 years.
- Karnofsky performance status (KPS) of greater than or equal to 60.
- Laboratory values (performed within 14 days prior to study drug administration, inclusive).
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >100,000/mm3
- Hemoglobin >10 g/dl or 100 g/l
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- BUN and serum creatinine <1.5 times upper limit of laboratory normal
- Total and direct bilirubin <1.5 times upper limit of laboratory normal
- SGOT and SGPT < 3 times upper limit of laboratory normal
- Alkaline Phosphatase < 3 times upper limit of laboratory normal
- A life expectancy from disease outside the CNS of greater than 12 weeks.
- Subjects must give written informed consent.
- Subjects must have histologically confirmed advanced solid malignancy with brain metastases, with or without systemic disease.
- Subjects must have failed or refused prior standard therapy for cerebral metastases and have imaging evidence of progressive disease. Prior therapy may include surgery and/or whole brain radiotherapy and/or stereotactic radiosurgery.
- At least 2 weeks must have elapsed since the completion of radiotherapy at any site other than brain, prior to start of study medication. At least 4 weeks must have elapsed since the completion of brain radiotherapy.
- At least 4 weeks must have elapsed since systemic therapy prior to start of study medication, all clinically significant toxicities (other than hair loss) must have resolved, and the patient must meet the eligibility criteria.
- Systemic disease may be absent, present and controlled or present and uncontrolled. If uncontrolled, the systemic disease should be considered less life-threatening than the cerebral disease. Patients may have received adjuvant chemotherapy and may have received one or more chemotherapy regimens for metastatic disease.
- Patients with breast cancer who have progressive brain metastases, but stable systemic disease whilst on hormonal therapy, may continue the same hormonal therapy, as it can be assumed that the blood brain barrier is preventing response to this agent in the central nervous system (CNS).
- Bidimensionally measurable disease must be documented in the brain on gadolinium magnetic resonance imaging (GdMRI) scan of the brain within 14 days prior to enrollment into the study. In the case of patients who received prior radiotherapy, the MRI scan findings must be consistent with progressive disease following treatment.
- Subjects who have had previous surgery or stereotactic radiotherapy must have lesions clearly measurable and distinct from the surgical and/or radiation changes induced by prior or local therapies.
- Subjects may be treated with steroids before initiation of protocol therapy and will be eligible if they are neurologically stable or improving.
Who cannot join
- No recovery from all active toxicities of prior therapies (other than hair loss).
- Surgery within 1 week (inclusive) prior to study drug administration, otherwise may be eligible providing acute toxicity is resolved.
- Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
- Concurrent primary malignancies at other sites with the exception of surgically cured carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
- Known HIV positivity or AIDS-related illness.
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- Pregnant or nursing women.
- Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions.
- Men who do not agree to use an effective method of contraception.
- Chemotherapy (excluding nitrosurea, mitomycin C or vincristine), within four weeks, inclusive, prior to study drug administration; biologic therapy or immunotherapy within two weeks, inclusive, prior to study drug administration.
- Nitrosurea or mitomycin C administration within six weeks, inclusive, prior to study drug administration.
- Completion of radiation therapy to sites outside the brain or interstitial brachytherapy within 2 weeks prior to study drug administration.
- Known carcinomatous meningitis.
- Lymphoma.
- Planned radiation therapy to systemic site.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.
Read the detailed description
OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.
- Conditions
- Metastatic Cancer
- Being tested
- temozolomide
- Keywords
- tumors metastatic to brain
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temodar, Temodal
Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| temozolomide | Experimental | Administered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2. Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide
Measured: 2 years
Secondary outcomes (3)
To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population
Measured: 2 years
to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide
Measured: 2 years
To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2004 (estimated)
- Study startOct 2000
- Primary completionApr 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Judith M. Ford, MD, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00012116
- Sponsor's protocol ID
- CDR0000068485
- Other IDs
- UCLA-0004059, SPRI-UCLA-0004059, NCI-G01-1919
- Status last verified
- Jul 2012
- First submitted
- 3 Mar 2001
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide For Patients With Cerebral Metastases Who Have Failed Radiation Therapy
- ClinicalTrials.gov ID
- NCT00012116
- Acronym / sponsor ID
- CDR0000068485
- Conditions
- Metastatic Cancer
- Keywords
- tumors metastatic to brain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Oct 2000
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 1 Jan 2004 (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.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors that have spread to the brain.
Detailed description
OBJECTIVES: I. Assess the response rate of patients with cerebral metastases who have failed or refused standard therapy when treated with temozolomide. II. Assess the safety and tolerability of this drug in these patients. III. Determine the quality of life of patients treated with this drug. IV. Determine the response rate of systemic disease outside the central nervous system in patients treated with this drug.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Treatment repeats every 10 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed on day 1 of each 10-week course. Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 18-48 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| temozolomide | Experimental | Drug: temozolomideAdministered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age greater than or equal to 18 years.
- Karnofsky performance status (KPS) of greater than or equal to 60.
- Laboratory values (performed within 14 days prior to study drug administration, inclusive).
- Absolute neutrophil count (ANC) >1500/mm3
- Platelet count >100,000/mm3
Key exclusion criteria (15 listed)
- No recovery from all active toxicities of prior therapies (other than hair loss).
- Surgery within 1 week (inclusive) prior to study drug administration, otherwise may be eligible providing acute toxicity is resolved.
- Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics.
- Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction).
- Concurrent primary malignancies at other sites with the exception of surgically cured carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible.
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 |
|---|---|---|
| temozolomideAlso: Temodar, TemodalAdministered in a fasting state, once a day for 6 weeks followed by 4 weeks of rest. Cycles may be repeated every 10 weeks until patients have evidence of progressive disease, intolerable toxicity or unwillingness to continue therapy. Daily dose: 75mg/m2. | Drug | temozolomide |
Primary outcome
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide
Time frame: 2 years
3 secondary outcomes
To assess the safety and tolerability of low dose, continuous oral temozolomide in this patient population
Time frame: 2 years
to measure quality of life in patients with cerebral metastases treated with low dose, continuous temozolomide
Time frame: 2 years
To measure the rate of response of systemic disease outside the central nervous system to extended low dose continuous oral temozolomide
Time frame: 2 years
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 3 Aug 2020.
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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.
Judith M. Ford, MD, PhD principal investigator
Jonsson Comprehensive Cancer Center
1 site 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 in people with Metastatic Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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?
The sponsor lists 21 inclusion and 15 exclusion criteria. 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To assess the rate of response/control of cerebral metastases from solid tumors to extended low dose, continuous oral temozolomide (time frame: 2 years). 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 3 Aug 2020.