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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-04-30

Study Completion Date

2000-03-31

Brief Summary

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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.

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Detailed Description

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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

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Brain Neoplasms Glioma Medulloblastoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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RMP-7 and carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Measurable or evaluable disease on radiographic studies with evidence of progression on prior chemotherapy or radiotherapy or persistent disease after surgery.

PRIOR/CURRENT THERAPY:

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes