A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors

Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors

NCT00001502•National Cancer Institute (NCI)

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. 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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
+25 more criteria

Locations (1)

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Key Dates

Start Date

April 1, 1996

Completion Date

March 1, 2000

Last Updated

March 4, 2008

Enrollment

Estimated participants

Conditions

Brain NeoplasmsGliomaMedulloblastoma

Interventions

RMP-7 and carboplatin

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors

Inclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors