Brain and Central Nervous System TumorsPhase 1NCT00004080
Gene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors
A Phase 1 study testing recombinant adenovirus-p53 SCH-58500 and conventional surgery in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI).
Trial summary
RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's ability to fight cancer. PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic… 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?
- recombinant adenovirus-p53 SCH-58500 and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1999to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma Progressive or recurrent disease following radiotherapy (54-64 Gy) and/or chemotherapy Tumor recurrence must have anatomic characteristics that allow safe and reasonable surgical intervention Measurable disease by serial MR or CT imaging No Li-Fraumeni syndrome or known germline defect in p53 gene No radiographically or surgically proven gliomatosis cerebri No tumors requiring immediate excision due to impending neurologic decline
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 25% Hepatic: Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal (ULN) PT or PTT no greater than ULN Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No uncontrolled hypertension No uncontrolled or unstable angina pectoris No uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No other active malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled or serious concurrent infection or other serious medical illness that would preclude study therapy No viral syndrome diagnosed within 2 weeks prior to study No other underlying medical condition that would increase risk of study or obscure interpretation of adverse results No active adenoviral infection
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered No concurrent biologic therapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No prior interstitial chemotherapy such as Gliadel wafer implantation for present brain tumor No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy Radiotherapy: See Disease Characteristics No prior brachytherapy for present brain tumor At least 3 months since other prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics No prior radiosurgery for present brain tumor At least 3 weeks since other prior oncologic surgery No other concurrent oncologic surgery Other: No other concurrent investigational drugs
About this study
Official title: Assessment of the Safety and Transduction Efficiency of SCH58500, An Adenoviral Vector p53 Delivery System, to Patients With Recurrent Malignant Brain Tumors
RATIONALE: Inserting the gene for p53 into a person's brain cells may improve the body's ability to fight cancer.
PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma that can be removed during surgery.
Read the detailed description
OBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53 delivered stereotactically to patients with recurrent or progressive resectable glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with postdelivery p53 gene status, clinical status, and tumor staging in these patients treated with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and local tumor immune response with postdelivery clinical status and tumor imaging in these patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at day 28, then every 2 months for 1 year, and then annually thereafter, until another therapy is begun or disease progression is documented.
PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27 months.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- recombinant adenovirus-p53 SCH-58500, conventional surgery
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Glioma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant adenovirus-p53 SCH-58500Biological
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startDec 1999
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 National Cancer Institute (NCI)The 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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jeffrey J. Olson, MD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004080
- Sponsor's protocol ID
- CDR0000067291
- Other IDs
- NABTT-9703, JHOC-NABTT-9703
- Status last verified
- Aug 2001
- First submitted
- 10 Dec 1999
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Transduction Efficiency of SCH58500, An Adenoviral Vector p53 Delivery System, to Patients With Recurrent Malignant Brain Tumors
- ClinicalTrials.gov ID
- NCT00004080
- Acronym / sponsor ID
- CDR0000067291
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 1999
- First posted
- 5 Aug 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: Inserting the gene for p53 into a person's brain cells may improve the body's ability to fight cancer.
PURPOSE: Phase I trial to study the effectiveness of p53 gene therapy with SCH-58500 in treating patients who have recurrent, or progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma that can be removed during surgery.
Detailed description
OBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53 delivered stereotactically to patients with recurrent or progressive resectable glioblastoma multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with postdelivery p53 gene status, clinical status, and tumor staging in these patients treated with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and local tumor immune response with postdelivery clinical status and tumor imaging in these patients treated with this regimen.
OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at day 28, then every 2 months for 1 year, and then annually thereafter, until another therapy is begun or disease progression is documented.
PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27 months.
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 |
|---|---|---|
| recombinant adenovirus-p53 SCH-58500 | Biological | – |
| conventional surgery | Procedure or surgery | – |
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 9 Feb 2009.
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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.
Jeffrey J. Olson, MD study chair
Emory University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant adenovirus-p53 SCH-58500 and conventional surgery in people with Brain and Central Nervous System Tumors, run by National Cancer Institute (NCI).
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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 9 Feb 2009.