Brain and Central Nervous System TumorsPhase 1NCT00052624
Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma
A Phase 1 study testing transferrin-CRM107 in people with Brain and Central Nervous System Tumors, run by Xenova Biomedix at 2 sites in United States.
Trial summary
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- transferrin-CRM107
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the following tumor characteristics:
- Unifocal
- Unilateral and supratentorial
- Diameter no greater than 3.5 cm by contrast-enhanced MRI
- No more than 1 satellite tumor
- Recurrent or progressive disease
- Progressive disease defined as at least 25% increase in tumor volume by serial MRI or CT scans and/or at least 15% increase in the largest cross-sectional area of tumor as defined by the area of contrast agent enhancement
- Must have received prior conventional treatment comprising both of the following:
- Surgery (biopsy or debulking)
- Radiation therapy
- No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness, or clinically significant papilledema
PATIENT CHARACTERISTICS:
Age
- 5 to 18
Performance status
- Karnofsky 60-100% OR
- Lansky Play 50-100%
Life expectancy
- At least 3 months
Hematopoietic
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 2.5 times the upper limit of normal (ULN)
- PT or aPTT no greater than 1.5 times ULN
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 2 months after study
- No acute viral, bacterial, or fungal infection requiring therapy
- Topical treatment for oral candidiasis allowed
- No other concurrent medical condition that would preclude anesthesia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior transferrin-CRM107
Chemotherapy
- More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- More than 3 months since prior biodegradable polymer wafers
- No concurrent chemotherapy
Endocrine therapy
- Must be on stable dose of steroids for 7 days prior to infusion
Radiotherapy
- See Disease Characteristics
- More than 3 months since prior radiotherapy
- More than 3 months since prior stereotactic radiosurgery
- More than 6 weeks since prior craniospinal irradiation
- No prior brachytherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- More than 1 month since prior surgery including tumor surgery or debulking
- No other concurrent surgery
Other
- More than 30 days since prior investigational agents
- No other concurrent investigational therapy
- No other concurrent anti-cancer drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Hospital of Orange County
Orange, California, 92868-3874
About this study
Official title: A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma.
- Determine the safety of this drug in these patients.
- Determine the efficacy of this drug in these patients.
- Compare the efficacy of this drug in patients with different histological types of tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody titer levels.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups by age (5-9 vs 10-18).
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).
- Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter. Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose (MTD) is determined.
- Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined.
The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months and then every 3 months for 6 months.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- transferrin-CRM107
- Keywords
- recurrent childhood cerebral astrocytoma
- Medical subject headings
- Central Nervous System Neoplasms, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transferrin-CRM107Biological
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 startJul 2002
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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Xenova Biomedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick Rossi, MD, Study chair, Xenova Biomedix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052624
- Sponsor's protocol ID
- MUSC-10550
- Other IDs
- KSB-311P/CI/001, CDR0000258574
- Status last verified
- Apr 2004
- First submitted
- 24 Jan 2003
- Last updated
- 15 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
- ClinicalTrials.gov ID
- NCT00052624
- Acronym / sponsor ID
- MUSC-10550
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent childhood cerebral astrocytoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Xenova BiomedixIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- 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: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma.
- Determine the safety of this drug in these patients.
- Determine the efficacy of this drug in these patients.
- Compare the efficacy of this drug in patients with different histological types of tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody titer levels.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups by age (5-9 vs 10-18).
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).
- Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter. Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose (MTD) is determined.
- Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined.
The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months and then every 3 months for 6 months.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 18 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 |
|---|---|---|
| transferrin-CRM107 | Biological | – |
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 15 May 2018.
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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.
Patrick Rossi, MD study chair
Xenova Biomedix
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transferrin-CRM107 in people with Brain and Central Nervous System Tumors, run by Xenova Biomedix at 2 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: status not confirmed, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
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 15 May 2018.