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Alkylating agents

Melphalan for Medulloblastoma

Phase 1 & 2
Waitlist Available
Led By Edward A Neuwelt
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dosage of melphalan when given with carboplatin and mannitol to see how well it works in treating patients with a brain tumor that is growing, spreading, or recurrent.

Eligible Conditions
  • Medulloblastoma
  • Brain Stem Glioma
  • Primitive Neuroectodermal Tumor
  • Central Nervous System Tumor
  • Embryonal Tumor With Multilayered Rosettes
  • Germ Cell Tumors
  • Neuroectodermal Tumors
  • Medulloepithelioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (Phase I)
Response rate (Phase II)
Secondary outcome measures
Change in neurocognitive assessment scores (Phase II)
Overall survival rate (Phase II)
Progression free survival rate (Phase II)
+1 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (mannitol, melphalan, carboplatin, STS)Experimental Treatment6 Interventions
Patients receive mannitol IA over 30 seconds, melphalan IA over 10 minutes, and carboplatin IA over 10 minutes. Patients then receive sodium thiosulfate IV over 15 minutes at 4 and 8 hours after carboplatin. Treatment repeats every 4-6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Mechlorethamine
FDA approved
Thiosulfuric acid
FDA approved
Mannitol
FDA approved

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
7,385,795 Total Patients Enrolled
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,709 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,347 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people of retirement age still being included in this research project?

"This trial only enrolls patients that fall between 18 and 45 years old."

Answered by AI

Are there any vacancies in this clinical trial for new test subjects?

"The study in question is not recruiting patients at the moment, as per the clinicaltrials.gov website. This trial was first posted on July 9th, 2009 and updated most recently on October 25th, 2021. Even though this specific study isn't looking for participants, there are 4260 other trials that have active recruitment going on right now."

Answered by AI

Are there any other investigations that have been done using Melphalan?

"Melphalan was first assessed in 2002 by H Central de Asturias. As of now, 1263 studies have been completed with 779 clinical trials still active. A considerable amount of these investigations are taking place in Minneapolis, Minnesota."

Answered by AI

Why is Melphalan prescribed to patients?

"Melphalan is a medication that is frequently used to help those with advanced sarcoma, but it can also be effective for managing increased intra ocular pressure (iop), initial treatment, and advanced thymoma."

Answered by AI

Who meets the screening criteria for this clinical trial?

"This clinical trial is searching for 17 patients that have medulloblastoma and are between the ages of 18-45. In order to be eligible, potential patients must not have received any radiation therapy treatment within the past 60 days and must have a Karnofsky performance status (KPS) of 50% or higher."

Answered by AI

What are the researchers ultimately hoping to find out by conducting this clinical trial?

"The goal of this trial is to find the maximum tolerated dose (Phase I), with secondary outcomes including progression free survival rate (Phase II) and proportion of patients with ototoxicity (Phase II). The trial will last for up to 5 years, and data will be collected on changes in neurocognitive assessment scores (Phase II)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors
Edward Neuwelt 2009. "Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00983398.
~1 spots leftby Apr 2025
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