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Phase I/II Study of Intra-arterial Melphalan Given With Intra-arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors


Phase 1/Phase 2
1 Year
30 Years
Open (Enrolling)
Both
Central Nervous System Embryonal Tumor, Germ Cell Tumors

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Trial Information

Phase I/II Study of Intra-arterial Melphalan Given With Intra-arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors


PHASE I PRIMARY OBJECTIVE To determine the maximum tolerated dose (MTD) of IA melphalan
given with IA carboplatin, osmotic BBBD and delayed IV STS in subjects with recurrent or
progressive embryonal and germ cell tumors of the CNS.

PHASE II PRIMARY OBJECTIVE To estimate the response rate in subjects with recurrent or
progressive CNS embryonal and germ cell tumors treated with IA carboplatin, IA melphalan,
osmotic BBBD and delayed IV STS.

SECONDARY OBJECTIVES

- To describe 2-year progression-free survival (PFS) and overall survival (OS) rates in
subjects with recurrent or progressive CNS embryonal and germ cell tumors treated with
IA carboplatin, IA melphalan, osmotic BBBD and delayed IV STS.

- To describe neuropsychological and audiology outcomes in subjects with recurrent or
progressive CNS embryonal and germ cell tumors treated with IA carboplatin, IA
melphalan, osmotic BBBD and delayed IV STS.

- To describe the overall toxicity of IA carboplatin and IA melphalan in conjunction with
osmotic BBBD and delayed STS chemoprotection in subjects with recurrent or progressive
CNS embryonal or germ cell tumors.


Inclusion Criteria:



- Subjects with histologically confirmed CNS embryonal tumor (PNET, medulloblastoma,
ATRT, medulloepithelioma, pineoblastoma or ependymoblastoma), or germ cell tumor

- Subjects must have had prior therapy according to the best available therapy as
determined by their primary brain tumor specialist (to include oncology, neurosurgery
and/or radiation oncology) including systemic and/or cranial radiation or
chemotherapy. At least 14 days must have elapsed since completion of cranial
radiotherapy and 28 days since completion of chemotherapy. At least 28 days must have
elapsed since completion of total spine radiotherapy

- Subjects must have a consultation with a radiation oncologist or providers must have
a discussion in the context of Neuro-Oncology Tumor Board within 28 days prior to
start of IA/BBBD chemotherapy to determine the need for radiotherapy prior to or
after IA/BBBD.

- For the phase II portion of the study, subjects must have disease that is evaluable
for response per Section 8.4. Subjects who have had radiation to all sites of
disease are not eligible unless there has been documented radiographic progression of
tumors subsequent to radiation

- Age greater or equal to 1 year and less than 30 years of age

- Baseline laboratory data should be the following:

- GFR greater than 30

- Absolute granulocyte count greater or equal to 1.0 x 103/mm3

- Platelets greater or equal to 100 x 103/mm3

- Creatinine < 1.5

- Total Bilirubin < 2.0

- AST/ALT < 2.5x upper limits of normal

- Karnofsky Performance Status (KPS) must be greater than or equal to 50%

- Subjects or their legal guardian must sign a written informed consent in accordance
with institutional guidelines

- Sexually active women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study treatment and for the duration of study treatment.

Exclusion Criteria:

- radiographic signs of excessive intracranial mass effect with associated rapid
neurologic deterioration and/or spinal cord block

- significant risk with general anesthesia

- uncontrolled (over the last 30 days) clinically significant confounding medical
conditions

- pregnant or lactating

- contraindications to carboplatin, melphalan, or STS

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PHASE I: PRIMARY OBJECTIVE To determine the maximum tolerated dose (MTD) of IA melphalan given with IA carboplatin, osmotic BBBD and delayed IV STS in subjects with recurrent or progressive embryonal and germ cell tumors of the CNS.

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

Edward A Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

OHSU-5056

NCT ID:

NCT00983398

Start Date:

September 2009

Completion Date:

December 2015

Related Keywords:

  • Central Nervous System Embryonal Tumor
  • Germ Cell Tumors
  • CNS embryonal tumor
  • cognitive/functional effects
  • drug toxicity
  • response rate
  • survival times
  • maximum tolerated dose (MTD) of IA melphalan/IA carboplatin
  • 2-year progression-free survival (PFS) and overall survival (OS) rates
  • Carcinoma, Embryonal
  • Neoplasms, Germ Cell and Embryonal

Name

Location

University of MinnesotaMinneapolis, Minnesota  55455
Oregon Health & Science UniversityPortland, Oregon  97201