Brain NeoplasmsPhase 1NCT00001502
A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
A Phase 1 study testing RMP-7 and carboplatin in people with Brain Neoplasms and Glioma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Neoplasms, Glioma, Medulloblastoma
- What is being tested?
- RMP-7 and carboplatin
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1996to Mar 2000
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
Histologically confirmed brain tumor including but not limited to the following: Anaplastic astrocytoma, Glioblastoma multiforme, Low-grade glioma, Ependymoma, Medulloblastoma, Pineal tumors, Chiasmal glioma, Craniopharyngioma, Brain stem glioma (requirement for histologic diagnosis may be waived).
Disease refractory to standard therapy or no standard chemotherapy exists and ineligible for potential curative surgery or radiotherapy.
Measurable or evaluable disease on radiographic studies with evidence of progression on prior chemotherapy or radiotherapy or persistent disease after surgery.
PRIOR/CURRENT THERAPY:
See Disease Characteristics
At least 6 months since carboplatin.
At least 3 weeks since myelosuppressive therapy.
Patients who received stem cell or bone marrow rescue after nitrosourea therapy are eligible after 3 weeks if they have recovered from hematologic toxicities of their prior therapy.
Concurrent steroids allowed if dose stable for at least 2 weeks prior to entry.
Recovered from toxic effects of any prior therapy.
PATIENT CHARACTERISTICS:
Age: 21 and under.
Performance status: ECOG 0-2.
Life expectancy: At least 8 weeks.
HEMATOLOGIC:
Absolute granulocyte count greater than 1,500/mm(3).
Platelet count greater than 100,000/mm(3) (at least 75,000/mm(3) in patients with prior bone marrow transplantation or craniospinal irradiation).
Hemoglobin greater than 8.0 g/dL.
HEPATIC:
Bilirubin no greater than 2 times normal.
ALT no greater than 2 times normal.
RENAL:
Creatinine within normal limits for age as follows:
Age (in years) -- Creatinine (in mg/dL):
Younger than 5 -- no greater than 1.2;
5-10 -- no greater than 1.5;
10-15 -- no greater than 1.8;
Older than 15 -- no greater than 2.4.
OTHER:
No significant systemic illness.
No pregnant or nursing women.
Negative pregnancy test required of fertile women.
Effective contraception required of fertile patients.
Durable power of attorney required of all patients 18-21 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
Read the detailed description
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
- Conditions
- Brain Neoplasms, Glioma, Medulloblastoma
- Being tested
- RMP-7 and carboplatin
- Keywords
- Blood-Brain Barrier, Bradykinin, Children, Glioma, Medulloblastoma
- Medical subject headings
- Brain Neoplasms, Glioma, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMP-7 and carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startApr 1996
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies 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
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001502
- Sponsor's protocol ID
- 960068
- Other IDs
- 96-C-0068
- Status last verified
- Feb 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Clements JA. The human kallikrein gene family: a diversity of expression and function. Mol Cell Endocrinol. 1994 Feb;99(1):C1-6. doi: 10.1016/0303-7207(94)90138-4. No abstract available.
PubMed 8187947Straub JA, Akiyama A, Parmar P. In vitro plasma metabolism of RMP-7. Pharm Res. 1994 Nov;11(11):1673-6. doi: 10.1023/a:1018986510570. No abstract available.
PubMed 7870689Inamura T, Nomura T, Bartus RT, Black KL. Intracarotid infusion of RMP-7, a bradykinin analog: a method for selective drug delivery to brain tumors. J Neurosurg. 1994 Nov;81(5):752-8. doi: 10.3171/jns.1994.81.5.0752.
PubMed 7931623
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
- ClinicalTrials.gov ID
- NCT00001502
- Acronym / sponsor ID
- 960068
- Conditions
- Brain Neoplasms, Glioma, Medulloblastoma
- Keywords
- Blood-Brain Barrier, Bradykinin, Children, Glioma, Medulloblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 1996
- Study completion
- Mar 2000
- First posted
- 10 Dec 2002 (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.
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
Detailed description
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 |
|---|---|---|
| RMP-7 and carboplatin | Drug | – |
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 4 Mar 2008.
- Background: PubMed 8187947Clements JA. The human kallikrein gene family: a diversity of expression and function. Mol Cell Endocrinol. 1994 Feb;99(1):C1-6. doi: 10.1016/0303-7207(94)90138-4. No abstract available.
- Background: PubMed 7870689Straub JA, Akiyama A, Parmar P. In vitro plasma metabolism of RMP-7. Pharm Res. 1994 Nov;11(11):1673-6. doi: 10.1023/a:1018986510570. No abstract available.
- Background: PubMed 7931623Inamura T, Nomura T, Bartus RT, Black KL. Intracarotid infusion of RMP-7, a bradykinin analog: a method for selective drug delivery to brain tumors. J Neurosurg. 1994 Nov;81(5):752-8. doi: 10.3171/jns.1994.81.5.0752.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RMP-7 and carboplatin in people with Brain Neoplasms and Glioma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
On the ClinicalTrials.gov record for NCT00001502, which also lists 3 linked publications.
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 4 Mar 2008; AzTrials last refreshed its copy on 8 Nov 2026.