Brain and Central Nervous System TumorsPhase 2NCT00006916
Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
A Phase 2 study testing bleomycin, Ommaya reservoir and radiation therapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 13 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor 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
- What is being tested?
- bleomycin, Ommaya reservoir and radiation therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 13 sitesUnited States
- Study dates
- Jun 2001to Dec 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study
- Tumor and/or any associated edema limited to one hemisphere and unifocal
- No gross invasion of a ventricular surface
- Tumor accessible
- No other astrocytoma
- No multifocal or recurrent malignant glioma
- No disease below the tentorium or beyond the cranial vault
PATIENT CHARACTERISTICS:
Age:
- Adult
Performance status:
- Zubrod 0-1
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Hemoglobin at least 10 g/dL (transfusion allowed)
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal
Renal:
- Blood Urea Nitrogen (BUN) no greater than 25 mg/dL
- Creatinine no greater than 1.5 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No hypersensitive or idiosyncratic reaction to bleomycin
- No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder
- No other major medical illness or psychiatric impairment that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for glioblastoma multiforme
- No prior radiosensitizer for glioblastoma multiforme
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0293
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
South Jersey Regional Cancer Center
Millville, New Jersey, 08332
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, 08060
Cottonwood Hospital Medical Center
Murray, Utah, 84107
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114-4199
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
LDS Hospital
Salt Lake City, Utah, 84143
Dixie Regional Medical Center
St. George, Utah, 84770
St. John Health System
Tulsa, Oklahoma, 74104
Cancer Treatment Center
Wooster, Ohio, 44691
About this study
Official title: A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
- Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin.
- Determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks.
Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- bleomycin, Ommaya reservoir, radiation therapy
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycinBiological
Ommaya reservoirDevice
radiation therapyRadiation
60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy followed by bleomycin via Ommaya reservoir | Experimental | 60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression. Receives: Biological: bleomycin; Device: Ommaya reservoir; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Measured: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
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 startJun 2001
- Primary completionDec 2005
- Study completionDec 2005
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Roy A. Patchell, MD, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006916
- Sponsor's protocol ID
- RTOG-BR-0013
- Other IDs
- CDR0000068343
- Status last verified
- Nov 2015
- First submitted
- 6 Dec 2000
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
- ClinicalTrials.gov ID
- NCT00006916
- Acronym / sponsor ID
- RTOG-BR-0013
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 3 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
Detailed description
OBJECTIVES:
- Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin.
- Determine the feasibility of this regimen in these patients.
OUTLINE: This is a multicenter study.
Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks.
Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy followed by bleomycin via Ommaya reservoir | Experimental | Biological: bleomycin, Device: Ommaya reservoir, Radiation: radiation therapy60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression. |
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 |
|---|---|---|
| bleomycin | Biological | Radiation therapy followed by bleomycin via Ommaya reservoir |
| Ommaya reservoir | Device | Radiation therapy followed by bleomycin via Ommaya reservoir |
| radiation therapy60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin. | Radiation | Radiation therapy followed by bleomycin via Ommaya reservoir |
Primary outcome
Overall Survival
Time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Roy A. Patchell, MD principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
13 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 bleomycin, Ommaya reservoir and radiation therapy in people with Brain and Central Nervous System Tumors, run by Radiation Therapy Oncology Group at 13 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: stopped early, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 3 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.). 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 26 Oct 2020.