Brain and Central Nervous System TumorsPhase 2NCT00002876
Etoposide Plus Cisplatin in Treating Patients With Recurrent Ependymomas
A Phase 2 study testing cisplatin and etoposide in people with Brain and Central Nervous System Tumors, run by Mayo Clinic at 3 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- cisplatin and etoposide
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 1991to Jan 2005
- 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 ependymoma that is recurrent after radiotherapy Histologic confirmation of recurrence encouraged but not required in patients with pure ependymoma at diagnosis and unequivocal radiologic evidence of recurrence Histologic confirmation of recurrence required in patients with mixed histology at diagnosis Ependymoma at least 80% of histology No subependymoma Measurable or evaluable disease on imaging exam
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Hematopoietic: WBC at least 3,500 Platelets at least 130,000 Hepatic: Bilirubin no greater than 0.3 mg/dL above normal Renal: Creatinine no greater than 0.3 mg/dL above normal Cardiovascular: No NYHA class III/IV status Other: No uncontrolled infection No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cisplatin or etoposide At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Steroid dose stable for at least 1 week prior to entry if indicator lesion in CNS Radiotherapy: See Disease Characteristics At least 4 weeks since radiotherapy Surgery: Not specified
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
About this study
Official title: A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy.
Read the detailed description
OBJECTIVES: I. Assess the efficacy and toxicity of etoposide and cisplatin in patients with recurrent ependymomas.
OUTLINE: All patients receive cisplatin followed by etoposide on days 1-3. Treatment repeats every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity intervenes. The etoposide dose may be increased by 10% on subsequent courses if the white blood cell and platelet nadirs on the previous course are at least 3,000 and 100,000, respectively. Patients are followed every 2 months for 6 months, then every 3 months for 4.5 years.
PROJECTED ACCRUAL: A total of 35 patients will be entered over approximately 7 years if there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients.
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult myxopapillary ependymoma, adult anaplastic ependymoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Ependymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2004 (estimated)
- Study startOct 1991
- Primary completionApr 1998
- Study completionJan 2005
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 Mayo ClinicThe 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
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Randolph S. Marks, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002876
- Sponsor's protocol ID
- CDR0000065162
- Other IDs
- P30CA015083, 907253, V96-1072, 394-91
- Status last verified
- May 2011
- First submitted
- 1 Nov 1999
- Last updated
- 11 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II TRIAL OF ETOPOSIDE AND CISPLATIN IN THE TREATMENT OF RECURRENT EPENDYMOMAS
- ClinicalTrials.gov ID
- NCT00002876
- Acronym / sponsor ID
- CDR0000065162
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult myxopapillary ependymoma, adult anaplastic ependymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1991
- Primary completion
- Apr 1998 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 21 May 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with recurrent ependymomas following radiation therapy.
Detailed description
OBJECTIVES: I. Assess the efficacy and toxicity of etoposide and cisplatin in patients with recurrent ependymomas.
OUTLINE: All patients receive cisplatin followed by etoposide on days 1-3. Treatment repeats every 4 weeks for a total of 6 courses unless disease progression or unacceptable toxicity intervenes. The etoposide dose may be increased by 10% on subsequent courses if the white blood cell and platelet nadirs on the previous course are at least 3,000 and 100,000, respectively. Patients are followed every 2 months for 6 months, then every 3 months for 4.5 years.
PROJECTED ACCRUAL: A total of 35 patients will be entered over approximately 7 years if there are 3-8 responses in the first 13 patients and 7-9 responses in the first 25 patients.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| cisplatin | Drug | – |
| etoposide | Drug | – |
Primary outcome
Not reported in the source record.
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 11 May 2011.
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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.
Randolph S. Marks, MD study chair
Mayo Clinic
3 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 cisplatin and etoposide in people with Brain and Central Nervous System Tumors, run by Mayo Clinic at 3 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 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 11 May 2011.