Brain TumorsPhase 1NCT00003625
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
A Phase 1 study testing cyclosporine, etoposide and vincristine sulfate in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 74 sites in 5 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Brain Tumors, Central Nervous System Tumors
- What is being tested?
- cyclosporine, etoposide and vincristine sulfate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 74 sitesin 5 countries
- Study dates
- Dec 1998to Apr 2006
- Phase
- Phase 1
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin of the tumor is clearly in the pons Must be registered within 28 days of diagnosis Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or ataxia) No diffuse leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal: Creatinine normal for age OR Creatinine clearance greater than 70 mL/min
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Trial locations and contacts
74 sites in 5 countries.
74 sites in 5 countries
United States65 sites
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87131
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
Eastern Maine Medical Center
Bangor, Maine, 04401
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
Floating Hospital for Children
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Vermont Cancer Center
Burlington, Vermont, 05401-3498
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
West Virginia University Medical School, Charleston Division
Charleston, West Virginia, 25304
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
Medical City Dallas Hospital
Dallas, Texas, 75230
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
Children's Hospital of Michigan
Detroit, Michigan, 48201
St. John's Hospital and Medical Center
Detroit, Michigan, 48236
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22046
Hurley Medical Center
Flint, Michigan, 48503
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, 76104
University of Texas Medical Branch
Galveston, Texas, 77555-1329
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Nemours Children's Clinic
Jacksonville, Florida, 32207
James H. Quillen College of Medicine
Johnson City, Tennessee, 37614-0622
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236-5300
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
Baptist Hospital of Miami
Miami, Florida, 33176-2197
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9162
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Christ Hospital
Oak Lawn, Illinois, 60453
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
Walt Disney Memorial Cancer Institute
Orlando, Florida, 32803
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602
Maine Children's Cancer Program
Portland, Maine, 04101
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24029
Sutter Cancer Center
Sacramento, California, 95816
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
Naval Medical Center - San Diego
San Diego, California, 92134-3202
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Washington University School of Medicine
St Louis, Missouri, 63110
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-9832
State University of New York - Upstate Medical University
Syracuse, New York, 13210
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
Scott and White Clinic
Temple, Texas, 76508
Arizona Cancer Center
Tucson, Arizona, 85724
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, 74136
St. Mary's Hospital
West Palm Beach, Florida, 33407
Via Christi Regional Medical Center-Saint Francis Campus
Wichita, Kansas, 67214
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma.
Read the detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of vincristine given as an IV push dose in combination with continuous infusion cyclosporine and oral etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of other toxicities of vincristine in this regimen in these patients. III. Determine a safe and tolerable dose of vincristine under these conditions to be used in phase II studies. IV. Seek preliminary evidence of antitumor activity in this setting in these patients.
OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion. Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12 patients per year.
- Conditions
- Brain Tumors, Central Nervous System Tumors
- Being tested
- cyclosporine, etoposide, vincristine sulfate, radiation therapy
- Keywords
- untreated childhood brain stem glioma
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
Also called CSA, NSC # 290193
etoposideDrug
Also called VP-16, VePesid, NSC # 141540
Also called VCR, Oncovin, NSC # 067574
radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1 | Experimental | Concomitant irradiation and vincristine sulfate in esc dose beginning with 0.8 mg/m2, etoposide and Cyclosporine A given over 6 weeks, then monthly maint courses over 6 mths, with no clinical and radiologic progression. Stable disease indicates continuation of therapy. Clinical deterioration within 4 months of completion of radiation therapy must be confirmed to be PD by imaging. Clinical progression even in the absence of imaging changes will be accepted as reflecting disease progression. Steroids dexamethasone (Decadron) given as clinically indicated and tapered as tolerated. Steroids may decrease capillary permeability to chemotherapeutic agents and antagonise the effect of cyclosporin A. Also contributes to the syndrome of seizures and white matter changes seen with cyclosporine in the post BMT period. If steroid use is required, the recommended schedule of Decadron dosing during the 6 week induction course is 8 mg/m2 divided q 6-8 hours. Receives: Drug: cyclosporine; Drug: etoposide; Drug: vincristine sulfate; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2004 (estimated)
- Study startDec 1998
- Primary completionFeb 2001
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark L. Greenberg, MD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003625
- Sponsor's protocol ID
- 9879
- Other IDs
- POG-9879, CDR0000066706
- Status last verified
- Jul 2014
- First submitted
- 1 Nov 1999
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine
- ClinicalTrials.gov ID
- NCT00003625
- Acronym / sponsor ID
- 9879
- Conditions
- Brain Tumors, Central Nervous System Tumors
- Keywords
- untreated childhood brain stem glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 1998
- Primary completion
- Feb 2001 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 13 Sep 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of vincristine given as an IV push dose in combination with continuous infusion cyclosporine and oral etoposide concurrent with and prior to radiotherapy in children with newly diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of other toxicities of vincristine in this regimen in these patients. III. Determine a safe and tolerable dose of vincristine under these conditions to be used in phase II studies. IV. Seek preliminary evidence of antitumor activity in this setting in these patients.
OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion. Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12 patients per year.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stratum 1 | Experimental | Drug: cyclosporine, Drug: etoposide, Drug: vincristine sulfate, Radiation: radiation therapyConcomitant irradiation and vincristine sulfate in esc dose beginning with 0.8 mg/m2, etoposide and Cyclosporine A given over 6 weeks, then monthly maint courses over 6 mths, with no clinical and radiologic progression. Stable disease indicates continuation of therapy. Clinical deterioration within 4 months of completion of radiation therapy must be confirmed to be PD by imaging. Clinical progression even in the absence of imaging changes will be accepted as reflecting disease progression. Steroids dexamethasone (Decadron) given as clinically indicated and tapered as tolerated. Steroids may decrease capillary permeability to chemotherapeutic agents and antagonise the effect of cyclosporin A. Also contributes to the syndrome of seizures and white matter changes seen with cyclosporine in the post BMT period. If steroid use is required, the recommended schedule of Decadron dosing during the 6 week induction course is 8 mg/m2 divided q 6-8 hours. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| cyclosporineAlso: CSA, NSC # 290193 | Drug | Stratum 1 |
| etoposideAlso: VP-16, VePesid, NSC # 141540 | Drug | Stratum 1 |
| vincristine sulfateAlso: VCR, Oncovin, NSC # 067574 | Drug | Stratum 1 |
| radiation therapy | Radiation | Stratum 1 |
Primary outcome
Event Free Survival
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 28 Jul 2014.
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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.
Mark L. Greenberg, MD study chair
The Hospital for Sick Children
74 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cyclosporine, etoposide and vincristine sulfate in people with Brain Tumors and Central Nervous System Tumors, run by Children's Oncology Group at 74 sites in 5 countries.
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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada, Netherlands, Puerto Rico, Switzerland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Event Free Survival. 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 28 Jul 2014.