Central Nervous System TumorsNCT00109798
Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
A study testing temozolomide and topotecan hydrochloride in people with Central Nervous System Tumors and Lymphoma, run by The Methodist Hospital Research Institute.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Nervous System Tumors, Lymphoma
- What is being tested?
- temozolomide and topotecan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Jul 2006
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma at initial diagnosis
- Measurable tumor by radiography
- Failed* OR is not a candidate for first-line high-dose systemic methotrexate-based chemotherapy with or without radiotherapy NOTE: *Failure is defined as relapse, progression, or failure to achieve a complete response
- PATIENT CHARACTERISTICS:
- Age
Show all 47Show fewer
- 18 and over
- Performance status
- Karnofsky 50-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Hepatic
- SGOT and SGPT ≤ 3 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL
- Renal
- Creatinine clearance > 40 mL/min
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No known allergy to temozolomide or topotecan
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer in complete remission
- No other major medical illness or psychiatric impairment that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent prophylactic growth factors
- Chemotherapy
- See Disease Characteristics
- At least 6 weeks since prior nitrosoureas
- At least 2 weeks since prior methotrexate
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- Surgery
- Not specified
- Other
- Recovered from all prior therapy
- At least 4 weeks since prior non-nitrosourea cytotoxic drugs (except methotrexate)
- At least 4 weeks since prior systemic investigational agents
- At least 2 weeks since prior non-cytotoxic antitumor drugs
- No other concurrent antitumor therapy
Who cannot join
- Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception.
- Known allergy to temozolomide or topotecan.
- Severe vomiting or other inability to administer medications orally.
- Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up.
About this study
Official title: Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan.
Secondary
- Determine the median and failure-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oral temozolomide once daily on days 1-5 and topotecan IV over 30 minutes once daily on days 2-6. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 6-25 patients will be accrued for this study.
- Conditions
- Central Nervous System Tumors, Lymphoma
- Being tested
- temozolomide, topotecan hydrochloride
- Keywords
- primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Medical subject headings
- Central Nervous System Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temodar
Patient will take drug on day 1-5 of 28 day schedule
topotecan hydrochlorideDrug
Also called Topotecan
Patient will have IV on days 2-6 on a 28-day schedule
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide, Topotecan | Experimental | Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule Receives: Drug: temozolomide; Drug: topotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete radiologic response (CR)
Measured: July 2006
Secondary outcomes (4)
Median overall survival
Measured: July 2006
Failure-free survival
Measured: July 2006
Toxicity
Measured: July 2006
Overall response rate (CR and partial response)
Measured: July 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startMar 2005
- Primary completionJul 2006
- Study completionJul 2006
Why it stopped: Sub-Investigator reloacted to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Pamela Z. New, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109798
- Sponsor's protocol ID
- BCM IRB#H-16155
- Other IDs
- CDR0000427313
- Status last verified
- Sep 2017
- First submitted
- 3 May 2005
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
- ClinicalTrials.gov ID
- NCT00109798
- Acronym / sponsor ID
- BCM IRB#H-16155
- Conditions
- Central Nervous System Tumors, Lymphoma
- Keywords
- primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sub-Investigator reloacted to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- Mar 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 4 May 2005 (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, such as temozolomide and topotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with topotecan works in treating patients with primary CNS lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan.
Secondary
- Determine the median and failure-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oral temozolomide once daily on days 1-5 and topotecan IV over 30 minutes once daily on days 2-6. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 6-25 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, Topotecan | Experimental | Drug: temozolomide, Drug: topotecan hydrochloridePatient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- Histologically confirmed primary CNS lymphoma at initial diagnosis
- Measurable tumor by radiography
- Failed* OR is not a candidate for first-line high-dose systemic methotrexate-based chemotherapy with or without radiotherapy NOTE: *Failure is defined as relapse, progression, or failure to achieve a complete response
- Age
- 18 and over
Key exclusion criteria (4 listed)
- Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception.
- Known allergy to temozolomide or topotecan.
- Severe vomiting or other inability to administer medications orally.
- Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up.
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: TemodarPatient will take drug on day 1-5 of 28 day schedule | Drug | Temozolomide, Topotecan |
| topotecan hydrochlorideAlso: TopotecanPatient will have IV on days 2-6 on a 28-day schedule | Drug | Temozolomide, Topotecan |
Primary outcome
Rate of complete radiologic response (CR)
Time frame: July 2006
4 secondary outcomes
Median overall survival
Time frame: July 2006
Failure-free survival
Time frame: July 2006
Toxicity
Time frame: July 2006
Overall response rate (CR and partial response)
Time frame: July 2006
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Pamela Z. New, MD study chair
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing temozolomide and topotecan hydrochloride in people with Central Nervous System Tumors and Lymphoma, run by The Methodist Hospital Research Institute.
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 47 inclusion and 4 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: withdrawn, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of complete radiologic response (CR) (time frame: July 2006). 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 19 Sep 2017.