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

This study has been completed.
Study NCT00001502.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
Official Title  Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
Brief 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

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 Phase Phase I
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Brain Neoplasms
Glioma
Medulloblastoma
Intervention  Drug: RMP-7 and carboplatin
MEDLINE PMIDs 8187947,   7870689,   7931623
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  30
Start Date  April 1996
Completion Date March 2000
Eligibility 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.

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.

Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001502
Organization ID 960068
Secondary IDs †† 96-C-0068
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date February 2000
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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