Brain and Central Nervous System TumorsPhase 3NCT00003788
Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas
A Phase 3 study testing carmustine, lomustine and porfimer sodium in people with Brain and Central Nervous System Tumors, run by Colorado Health Foundation at 4 sites in 2 countries.
Trial summary
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial… 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?
- carmustine, lomustine and porfimer sodium
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 1998to not given
- Phase
- Phase 3
- 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 newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma
- Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification
- Suitable for radical resection on the basis of imaging studies
- Patients with recurrent disease must have failed surgery and radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100% for newly diagnosed tumor
- Karnofsky 70-100% for recurrent tumor
Life expectancy:
- At least 3 months
Hematopoietic:
- Recurrent tumor:
- WBC at least 2,000/mm^3
- Platelet count at least 80,000/mm^3
Hepatic:
- Recurrent tumor:
- PT/PTT no greater than 1.5 times upper limit of normal (ULN)
- Bilirubin and LFTs less than 2 times ULN
- Alkaline phosphatase no greater than 3 times ULN
- GGT no greater than 3 times ULN
Renal:
- Creatinine no greater than 2 mg/dL
Other:
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior cranial radiotherapy for newly diagnosed tumor
Surgery:
- See Disease Characteristics
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Rocky Mountain Neurological Associates
Englewood, Colorado, 80110
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.
PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
Read the detailed description
OBJECTIVES:
- Determine whether the addition of photodynamic therapy to standard brain tumor care (surgical resection, postoperative radiotherapy, and chemotherapy) will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas.
- Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas.
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
- Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
- Arm I: Patients receive porfimer sodium (Photofrin) IV one day prior to surgery. Craniotomy and tumor resection are performed. Upon completion of resection, patients undergo intracavitary photoillumination with a high light dose.
- Arm II: Craniotomy and tumor resection are performed. Postoperatively, all patients receive external beam radiotherapy 5 days per week for 5-6 weeks. After completing radiotherapy, patients receive nitrosourea (carmustine or lomustine) chemotherapy.
Recurrent tumor patients (Study 2)
- Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed.
- Arm I: Patients receive high dose light therapy during surgery.
- Arm II: Patients receive low dose light therapy during surgery. Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure.
PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- carmustine, lomustine, porfimer sodium, procarbazine hydrochloride, neoadjuvant therapy
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
lomustineDrug
porfimer sodiumDrug
procarbazine hydrochlorideDrug
neoadjuvant therapyProcedure or surgery
surgical procedureProcedure or surgery
radiation therapyRadiation
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 1998
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Health Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Fred W. Hetzel, PhD, JD, Study chair, Colorado Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003788
- Sponsor's protocol ID
- CDR0000066927
- Other IDs
- HEALTHONE-43892, HEALTHONE-1A, HEALTHONE-CA43892, RPCI-DS-9802, NCI-V99-1525
- Status last verified
- Sep 2003
- First submitted
- 1 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors
- ClinicalTrials.gov ID
- NCT00003788
- Acronym / sponsor ID
- CDR0000066927
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Colorado Health FoundationUniversity, hospital or other
- Study start
- Apr 1998
- 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: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.
PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
Detailed description
OBJECTIVES:
- Determine whether the addition of photodynamic therapy to standard brain tumor care (surgical resection, postoperative radiotherapy, and chemotherapy) will result in a significant prolongation of time to recurrence and survival in newly diagnosed malignant supratentorial gliomas.
- Compare the effect of high or low light dose photodynamic therapy on survival of patients with recurrent malignant supratentorial gliomas.
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
- Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
- Arm I: Patients receive porfimer sodium (Photofrin) IV one day prior to surgery. Craniotomy and tumor resection are performed. Upon completion of resection, patients undergo intracavitary photoillumination with a high light dose.
- Arm II: Craniotomy and tumor resection are performed. Postoperatively, all patients receive external beam radiotherapy 5 days per week for 5-6 weeks. After completing radiotherapy, patients receive nitrosourea (carmustine or lomustine) chemotherapy.
Recurrent tumor patients (Study 2)
- Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed.
- Arm I: Patients receive high dose light therapy during surgery.
- Arm II: Patients receive low dose light therapy during surgery. Patients receive chemotherapy with procarbazine for 28 days beginning 2-4 weeks after surgery. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure.
PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
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 |
|---|---|---|
| carmustine | Drug | – |
| lomustine | Drug | – |
| porfimer sodium | Drug | – |
| procarbazine hydrochloride | Drug | – |
| neoadjuvant therapy | Procedure or surgery | – |
| surgical procedure | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Fred W. Hetzel, PhD, JD study chair
Colorado Health Foundation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carmustine, lomustine and porfimer sodium in people with Brain and Central Nervous System Tumors, run by Colorado Health Foundation at 4 sites in 2 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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 6 Nov 2013.