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Phase I Study of RMP-7 (a Bradykinin Analogue) and Carboplatin for Refractory Childhood Brain Tumors
Alternate Title Combination Chemotherapy in Treating Children With Refractory Childhood Brain Tumors
Objectives I. Estimate the maximum tolerated dose of RMP-7 (a bradykinin analogue) that can be given in combination with carboplatin (CBDCA) in pediatric patients with refractory brain tumors. II. Describe and define the toxic effects associated with this treatment. III. Define the plasma pharmacokinetics of CBDCA when administered with RMP-7. IV. Determine the activity of RMP-7/CBDCA against these tumors. Entry 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/Concurrent Therapy: Biologic therapy: At least 3 weeks since stem cell or bone marrow rescue after nitrosoureas and recovered Chemotherapy: See Disease Characteristics At least 6 months since carboplatin At least 6 weeks since nitrosoureas (except as specified in Biologic therapy) At least 3 weeks since other myelosuppressive therapy and recovered Endocrine therapy: Concurrent steroids allowed if dose stable for at least 2 weeks prior to entry Radiotherapy: See Disease Characteristics Recovered from any prior radiotherapy Surgery: See Disease Characteristics Recovered from any prior surgery Patient Characteristics: Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 (at least 75,000/mm3 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 Expected Enrollment It is anticipated that 30 patients will be entered over 1-2 years. Outline 2-Drug Combination Chemotherapy. RMP-7; Carboplatin, CBDCA, NSC-241240.Published Results Warren K, Gervais A, Aikin A, et al.: Pharmacokinetics of carboplatin administered with lobradimil to pediatric patients with brain tumors. Cancer Chemother Pharmacol 54 (3): 206-12, 2004.[PUBMED Abstract] Warren KE, Patel MC, Aikin AA, et al.: Phase I trial of lobradimil (RMP-7) and carboplatin in children with brain tumors. Cancer Chemother Pharmacol 48 (4): 275-82, 2001.[PUBMED Abstract] Warren KE, Patel MC, Adamson PC, et al.: Phase I trial of RMP-7 and carboplatin in pediatric patients with brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-764, 1998. Trial Lead Organizations Alkermes, Incorporated
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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