Neoplasms

All Conditions

Nervous System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Glioma

Glioblastoma

Medulloblastoma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Gliosarcoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Pinealoma

Sarcoma

Astrocytoma

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neuroepithelioma

Supratentorial Primitive Neuroectodermal Tumor

Pineoblastoma

Embryonal Tumor With Multilayered Rosettes

Pineocytoma

Soft Tissue Sarcoma

Ewing Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Temozolomide

Plerixafor

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide PO over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor IV continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.

radiation therapy

temozolomide

plerixafor

laboratory biomarker analysis

pharmacological study

Lawrence Recht

This pilot phase I/II trial studies the side effects and best dose of plerixafor after radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor after radiation therapy and temozolomide may be an effective treatment for high grade glioma.

PRIMARY OBJECTIVES:

I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in patients with newly diagnosed glioblastoma multiforme (GBM).

II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months (PFS6) from the start of irradiation.

OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.

Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally (PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.

After completion of study treatment, patients are followed up every 12 weeks for 5 years.

Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM

Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)

Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.

National Cancer Institute (NCI)

Professor of Neurology

One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 200 mcg/kg/day over 4 weeks.

Escalation: Plerixafor 200 mcg/kg/Day

One week prior to the completion of radiotherapy with concurrent temozolomide, patients with newly diagnosed glioblastoma will receive continuous infusion of Plerixafor at a dose of 400 mcg/kg/day over 4 weeks.

Escalation: Plerixafor 400 mcg/kg/Day

Expansion: Plerixafor 400 mcg/kg/Day

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Only subjects who completed the 4 week infusion were included

Lawrence Recht, MD, Professor of Neurology

Dose-limiting Toxicity

Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation

Overall Study

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Neoplasm Metastasis

Recurrence

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Prolymphocytic

Meningeal Neoplasms

Meningioma

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Leukemia, Hairy Cell

Ependymoma

Craniopharyngioma

Adamantinoma

Oligodendroglioma

Leukemia, Large Granular Lymphocytic

Choroid Plexus Neoplasms

Leukemia, Mast-Cell

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Brain Tumor, Adult

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Hairy Cell Leukemia

Childhood Brain Stem Glioma

Aggressive NK Cell Leukemia

T-cell Large Granular Lymphocyte Leukemia

Medulloblastoma, Childhood

Subependymal Giant Cell Astrocytoma

Cerebellar Astrocytoma, Childhood

Cerebral Astrocytoma, Childhood

Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified

questionnaire administration

psychosocial assessment and care

Elizabeth Fox, MD

RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.

PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.

OBJECTIVES:

* To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.

OUTLINE: This is a multicenter study.

Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.

Patient demographics and other relevant information are collected.

Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial

A Pharmacokinetic Participation Questionnaire Study

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma	NCT01977677	Adult Ependymob... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Medullobl... Adult Mixed Gli... Adult Oligodend... Adult Pineoblas... Adult Supratent...	radiation thera... temozolomide plerixafor laboratory biom... pharmacological...	18 Years - 75 Years	Stanford University
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial	NCT00890435	Brain and Centr... Leukemia Unspecified Adu... Unspecified Chi...	questionnaire a... psychosocial as...	18 Years -	Children's Oncology Group
Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma	NCT01977677	Adult Ependymob... Adult Giant Cel... Adult Glioblast... Adult Gliosarco... Adult Medullobl... Adult Mixed Gli... Adult Oligodend... Adult Pineoblas... Adult Supratent...	radiation thera... temozolomide plerixafor laboratory biom... pharmacological...	18 Years - 75 Years	Stanford University
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial	NCT00890435	Brain and Centr... Leukemia Unspecified Adu... Unspecified Chi...	questionnaire a... psychosocial as...	18 Years -	Children's Oncology Group

Spots Global Cancer Trial Database for adult oligodendroglial tumors