Brain TumorsPhase 2NCT00005812
Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
A Phase 2 study testing temozolomide in people with Brain Tumors and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumors, Central Nervous System Tumors, Leptomeningeal Metastases
- What is being tested?
- temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Documented leptomeningeal metastases
- Carcinomatous meningitis that is previously untreated or failed prior therapy OR
- Lymphomatous meningitis
- Systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious
- Age 18 and over
- Karnofsky Performance Status 60-100%
- Life expectancy of at least 6 weeks
- Absolute neutrophil count greater than 1,500/μL
- Platelet count greater than 100,000/μL
- Creatinine no greater than 2.0 mg/dL
- No congestive heart failure
- No unstable angina
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindication to diagnostic sampling of CSF via lumbar puncture or reservoir
- No medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting)
- No uncontrolled infection
- Prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed
- No other concurrent chemotherapy for other sites of disease
- No prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas
- No prior radiotherapy to greater than 30% of bone marrow
- Prior radiotherapy to the neuroaxis allowed
- No concurrent radiotherapy for other sites of disease or for progressive disease
- Recovered from any prior recent therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
About this study
Official title: A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.
- Determine adverse events related to this regimen in this patient population.
- Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.
Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.
PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
- Being tested
- temozolomide
- Keywords
- leptomeningeal metastases, temozolomide
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Oral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until:
* disease progression
* intolerable toxicity
* complete response - 2 full additional cycles
* if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response. Receives: Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
Response will be assessed clinically, cytologically, and radiographically.
Measured: Every 6 weeks
Secondary outcomes (3)
Pharmacokinetics
Drug levels in cerebrospinal fluid assessed every 6 weeks
Measured: Every 6 weeks
Survival
Measured: every 6 weeks
Quality of Life
FACT-Br
Measured: Baseline, weekly during cycle 1, before each additional cycle
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 startJan 2000
- Primary completionMay 2004
- Study completionMay 2004
Why it stopped: No objective response documented, protocol terminated after 12 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas H. Davis, MD, Study chair, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005812
- Sponsor's protocol ID
- D9812
- Other IDs
- DMS-9812, NCI-G00-1782
- Status last verified
- May 2013
- First submitted
- 2 Jun 2000
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Trial of Temozolomide in Leptomeningeal Metastases
- ClinicalTrials.gov ID
- NCT00005812
- Acronym / sponsor ID
- D9812
- Keywords
- leptomeningeal metastases, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No objective response documented, protocol terminated after 12 patients.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2000
- Primary completion
- May 2004 (actual)
- Study completion
- May 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 cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.
Detailed description
OBJECTIVES:
- Determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide.
- Determine adverse events related to this regimen in this patient population.
- Measure temozolomide concentrations in CSF and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients.
OUTLINE: Patients receive oral temozolomide daily for 6 weeks. Courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients with a CR except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response.
Quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter.
PROJECTED ACCRUAL: A total of 14-24 patients will be accrued for this study.
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: temozolomideOral temozolomide 75 mg/m2/day for 6 weeks, followed by 4 week break. Cycles will continue until: * disease progression * intolerable toxicity * complete response - 2 full additional cycles * if response is complete except for residual radiographic abnormalities that persist unchanged for 2 full cycles: continue for 4 cycles past best response. |
Who may qualify
- Ages
- 18 years and older
- 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 | Temozolomide |
Primary outcome
Objective Response
Time frame: Every 6 weeks
Response will be assessed clinically, cytologically, and radiographically.
3 secondary outcomes
Pharmacokinetics
Time frame: Every 6 weeks
Survival
Time frame: every 6 weeks
Quality of Life
Time frame: Baseline, weekly during cycle 1, before each additional cycle
Results and safety
The study was stopped early (reason given: No objective response documented, protocol terminated after 12 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Results publicationDavis TH, Fadul CE, Glantz MJ, et al.: Pilot phase II trial of temozolomide for leptomeningeal metastases: preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-460, 2003. ISBN 1932312021
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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.
Thomas H. Davis, MD study chair
Norris Cotton 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 Brain Tumors and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical 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?
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 14 May 2013. 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 was stopped early (reason given: No objective response documented, protocol terminated after 12 patients.). 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?
Objective Response (time frame: Every 6 weeks). 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 NCT00005812, 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 14 May 2013.