Brain and Central Nervous System TumorsPhase 2NCT00007982
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
A Phase 2 study testing filgrastim, carmustine and cisplatin in people with Brain and Central Nervous System Tumors and Head and Neck Cancer, run by Herbert Irving Comprehensive Cancer 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. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. 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, Head and Neck Cancer, Lymphoma
- What is being tested?
- filgrastim, carmustine and cisplatin
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to May 2008
- 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 malignant tumors
- Anaplastic astrocytoma
- Oligodendroglioma
- Germ cell tumor
- Medulloblastoma
- Primary neuroectodermal tumor
- Esthesioneuroblastoma
- CNS lymphoma (primary or systemic disease)
- Multifocal intracranial disease allowed
- No extraneural metastases (except controlled systemic lymphoma)
- Pretreatment considerations based on tumor type
- Anaplastic astrocytoma:
- Recurrent disease
- Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)
- Chemotherapy not required at recurrence
- Oligodendroglioma:
- Disease response (at least minor) to conventional chemotherapy OR
- Recurrent disease
- Esthesioneuroblastoma:
- Attempted complete surgical resection
- Disease progression after radiotherapy
- Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin
- CNS lymphoma:
- Disease refractory to methotrexate OR
- Failure after initial treatment with methotrexate OR
- Considered at high risk for disease relapse despite initial response
- Radiographic or pathological confirmation of recurrent disease required
- Not eligible for other high priority national or institutional clinical studies
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG or Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- LVEF at least 45%
Pulmonary:
- DLCO at least 60% predicted OR
- Approval of pulmonologist
Other:
- Not pregnant or nursing
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent anticancer hormonal therapy
- No concurrent steroids as antiemetics
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No concurrent barbiturates or acetaminophen
- Participation in other concurrent supportive care or gene therapy trials allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, 10032
About this study
Official title: CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy.
- Determine the disease-free survival and overall survival of this patient population treated with these regimens.
- Determine the toxicity of this high-dose chemotherapy regimen in these patients.
- Assess the quality of life of these patients following these treatment regimens.
OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy.
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation.
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy.
Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of life is assessed at follow-up.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.
- Being tested
- filgrastim, carmustine, cisplatin, cyclophosphamide, etoposide
- Keywords
- recurrent adult brain tumor, adult medulloblastoma, adult oligodendroglioma, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, adult anaplastic astrocytoma, adult central nervous system germ cell tumor, primary central nervous system non-Hodgkin lymphoma, adult anaplastic oligodendroglioma
- Medical subject headings
- Central Nervous System Neoplasms, Head and Neck Neoplasms, Lymphoma, Brain Neoplasms, Medulloblastoma, Oligodendroglioma, Esthesioneuroblastoma, Olfactory, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
carmustineDrug
cisplatinDrug
cyclophosphamideDrug
etoposideDrug
thiotepaDrug
adjuvant therapyProcedure or surgery
autologous bone marrow transplantationProcedure or surgery
bone marrow ablation with stem cell supportProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Disease-free suvival
Overall survival
Toxicity
Quality of life
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 startApr 1999
- Primary completionFeb 2005
- Study completionMay 2008
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herbert Irving Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Charles S. Hesdorffer, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007982
- Sponsor's protocol ID
- CDR0000068360
- Other IDs
- CPMC-IRB-8445, CPMC-CAMP-004A, NCI-G00-1881
- Status last verified
- Jul 2007
- First submitted
- 6 Jan 2001
- Last updated
- 4 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
- ClinicalTrials.gov ID
- NCT00007982
- Acronym / sponsor ID
- CDR0000068360
- Keywords
- recurrent adult brain tumor, adult medulloblastoma, adult oligodendroglioma, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, adult anaplastic astrocytoma, adult central nervous system germ cell tumor, primary central nervous system non-Hodgkin lymphoma, adult anaplastic oligodendroglioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Herbert Irving Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Feb 2005 (actual)
- Study completion
- May 2008 (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. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy.
- Determine the disease-free survival and overall survival of this patient population treated with these regimens.
- Determine the toxicity of this high-dose chemotherapy regimen in these patients.
- Assess the quality of life of these patients following these treatment regimens.
OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy.
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation.
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy.
Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of life is assessed at follow-up.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.
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 |
|---|---|---|
| filgrastim | Biological | – |
| carmustine | Drug | – |
| cisplatin | Drug | – |
| cyclophosphamide | Drug | – |
| etoposide | Drug | – |
| thiotepa | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| autologous bone marrow transplantation | Procedure or surgery | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Response rate
Disease-free suvival
Overall survival
Toxicity
Quality of life
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 4 Feb 2013.
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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.
Charles S. Hesdorffer, MD study chair
Herbert Irving 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 filgrastim, carmustine and cisplatin in people with Brain and Central Nervous System Tumors and Head and Neck Cancer, run by Herbert Irving 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?
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 4 Feb 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 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?
Response rate. The study lists 5 primary outcomes in all. 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 4 Feb 2013.