Melphalan With BBBD in Treating Patients With Brain Malignancies

Phase 1

Terminated

• Conditions: Lymphoma; Brain and Central Nervous System Tumors; Metastatic Cancer
• Interventions: Drug: Melphalan

• Registration Number: NCT00253721
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells. Mannitol may open the blood vessels around the brain \[Blood-Brain Barrier Disruption (BBBD)\]and allow melphalan to be carried directly to the brain tumor. Giving melphalan together with BBBD may be an effective treatment for central nervous system cancer.

PURPOSE: This phase I trial is studying side effects and best dose of melphalan when given together with mannitol in treating patients with central nervous system cancer.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of intra-arterial melphalan when given in combination with BBBD in patients with primary or metastatic central nervous system (CNS) malignancy.

* Determine the toxic effects of melphalan given with BBBD in these patients.

* Determine, preliminarily, the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of melphalan.

Patients receive intra-arterial mannitol with BBBD followed by intra-arterial melphalan over 10 minutes on days 1 and 2\*. Treatment repeats every 4 weeks for up to 12 monthly courses in the absence of disease progression or unacceptable toxicity .

NOTE: \*Patients with gliomas localized to the posterior circulation (i.e., brain stem gliomas) receive melphalan on day 1 only.

Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year; every 6 months for the next 2 years; then annually.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Primary Completion: 2015-12
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Melphalan	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)of Melphalan as measured by NCI common toxicity criteria (CTC) v2 toxicities	5 years	MTD = dose of Melphalan that produces grade 3 neurotoxicity in 33% of subjects

Secondary Outcome Measures

Name	Time	Method
Efficacy of chemotherapy regimen as measured by clinical and radiographic response from first day of treatment	5 years

Trial Locations

Locations (1)

Knight Cancer Institute at Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States