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


Phase 1
N/A
N/A
Not Enrolling
Both
Brain Neoplasms, Glioma, Medulloblastoma

Thank you

Trial Information

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.

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.

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

960068

NCT ID:

NCT00001502

Start Date:

April 1996

Completion Date:

March 2000

Related Keywords:

  • Brain Neoplasms
  • Glioma
  • Medulloblastoma
  • Blood-Brain Barrier
  • Bradykinin
  • Children
  • Glioma
  • Medulloblastoma
  • Brain Neoplasms
  • Neoplasms
  • Glioma
  • Medulloblastoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892