Melphalan With BBBD in Treating Patients With Brain Malignancies
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|ClinicalTrials.gov Identifier: NCT00253721|
Recruitment Status : Terminated (Other competing clinical trials affecting enrollment)
First Posted : November 15, 2005
Last Update Posted : April 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Lymphoma Metastatic Cancer||Drug: Melphalan||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-Arterial Melphalan (L-Phenylalanine Mustard) Administered in Conjunction With Osmotic Blood-Brain Barrier Disruption in Patients With Brain Malignancies: A Phase I Study|
|Study Start Date :||May 1998|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2016|
|Experimental: All subjects||
All levels: Every 4 weeks for up to one year
Dose Escalation Plan:
Level 1: 4mg/m2/day x 2 days
Level 2: 6mg/m2/day x 2 days
Level 3: 8mg/m2/day x 2 days
Level 4: 10mg/m2/day x 2 days
Level 5: 12mg/m2/day x 2 days
- Maximum tolerated dose (MTD)of Melphalan as measured by NCI common toxicity criteria (CTC) v2 toxicities [ Time Frame: 5 years ]MTD = dose of Melphalan that produces grade 3 neurotoxicity in 33% of subjects
- Efficacy of chemotherapy regimen as measured by clinical and radiographic response from first day of treatment [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253721
|United States, Oregon|
|Knight Cancer Institute at Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|Principal Investigator:||Edward A. Neuwelt, MD||OHSU Knight Cancer Institute|