Advertisement

Topics

Study of Systemic and Spinal Chemotherapy Followed by Radiation for Infants With Brain Tumors

2014-08-27 03:55:54 | BioPortfolio

Summary

The purposes of this study are to find the highest dose of mafosfamide that can be given without causing severe side effects, to see how well the combination of these chemotherapy drugs and lower doses of radiation work to delay or stop the growth of the tumor, and to evaluate the pharmacokinetics (how the body handles) of Mafosfamide.

Description

All children in the study will receive Regimen 1 chemotherapy. Children whose tumor is limited to one area at the beginning of the study will go on to have radiation therapy and then Regimen 2 chemotherapy. Children whose tumor was found in more than one part of the brain or in the cerebrospinal fluid at the beginning of the study will discontinue their treatment on this protocol after Regimen 1 chemotherapy.

Regimen 1 Chemotherapy - Those children with a normal CSF flow study at the beginning of the study will receive Regimen 1 chemotherapy along with mafosfamide. Those children with an abnormal CSF flow study will receive Regimen 1 without mafosfamide and a repeat CSF flow study will be performed at the completion of the first 10 weeks of treatment. If the CSF study reflects normal CSF flow, then intrathecal mafosfamide will be given during the second 10 weeks of Regimen 1. Regimen 1 is divided into two courses. Each course lasts about 10 weeks, for a total of 20 weeks of treatment. During Regimen 1 the patient will receive three medications (cyclophosphamide, vincristine, and cisplatin) that are given through the central venous line. The patient will also receive one medication that is given by mouth (etoposide). Cyclophosphamide, vincristine, cisplatin, and etoposide are all anticancer drugs that have been useful in the treatment of brain tumors.

The experimental drug, mafosfamide, will be injected into the spinal fluid. This will be given through either a spinal tap, the Ommaya reservoir, or both. Alternating mafosfamide between the spinal tap and the Ommaya reservoir may improve how well the drug works by making sure it spreads throughout the spinal fluid. If the patient has a VP or VA shunt ( specialized devices that relieve the pressure inside the head that comes from a block in the normal flow of spinal fluid), then the patient will not receive an Ommaya reservoir, and all doses of mafosfamide will be given through a spinal tap only.

The starting dose of mafosfamide will be a dose that has been safely given to older children. If that dose does not cause severe side effects, the next group of patients will receive a higher dose of mafosfamide. If severe side effects occur, the next group of patients will receive a lower dose of mafosfamide

During and at the end of Regimen 1, the patient will be evaluated for response of the brain tumor to treatment. A second operation may be necessary to remove more of the brain tumor. Children whose tumor had spread at the time they began this study have completed treatment at this point. Children whose tumor had not spread at start of the study will begin radiation therapy, if their tumor appears to be unchanged or shrinking after Regimen 1.

Radiation Therapy - The dose, location, and timing of radiation will depend on the age of the child at diagnosis, the location of his/her tumor, and the response of his/her tumor to Regimen 1 chemotherapy. The radiation treatments used in this protocol are designed in an attempt to reduce some of the side effects that usually occur after standard radiation therapy.

The child will receive radiation using a new technology called "conformal radiation". Conformal radiation is designed to reduce the amount of normal brain tissue that is exposed to high doses of radiation.

Regimen 2 Chemotherapy - After radiation therapy,the patient will receive additional chemotherapy, which will last about 20 weeks. Regimen 2 chemotherapy is the same as the Regimen 1 chemotherapy, except that the patient will not be given the drugs cisplatin and mafosfamide.

Pharmacokinetic (PK) studies will be performed with a total of 2 doses of intrathecal mafosfamide. PK studies tell us how the patient's body handles the study drug, mafosfamide. Sampling times (times when we collect cerebrospinal fluid for the PK studies) will be prior to drug administration and at 10 minutes, 2 hours, and 4 hours following drug administration. These studies will be performed after one dose of drug given through the spinal tap and after one dose of drug is given through the Ommaya reservoir. The pharmacokinetic study is optional and you can choose not to allow these samples to be drawn. Refusing the pharmacokinetic study will not affect the patient's participation/treatment on this study.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain Tumors

Intervention

Induction therapy (Regimen 1, Course 1, Cycle A1, Regimen 1, Course 1, Cycle A2 (Days 22 - 42), Cycle B, Regimen 1, Course 2, Intrathecal Mafosfamide, Regimen 1 Course 2, IT mafosfamide, Regimen 2, Course 1, Regimen 2, Course, 1, Cycle C1, Regimen 2, Cour

Location

Brain Tumor Center at Duke University
Durham
North Carolina
United States
27710

Status

Active, not recruiting

Source

Baylor College of Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:54-0400

Clinical Trials [4043 Associated Clinical Trials listed on BioPortfolio]

MRD/Risk-oriented Therapy of Adult Ph- ALL Including Pegylated Asparaginase and Lineage-targeted Methotrexate

This study will be conducted in different centres and will study adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). The study treatment will inc...

Subcutaneous (SC) Bortezomib-Regimens for Patients With RR MM Failing Prior IV Bortezomib-Containing Regimens

This is a phase 2, multicenter, open label, nonrandomized study for patients with MM who will receive treatment with a SC bortezomib-containing combination regimen that does not contain th...

Study of Lenalidomide(Revlimid) Plus Rituximab (Revlirit Regimen) in Elderly Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and da...

First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor EMD 1214063 in Subjects With Advanced Solid Tumors

This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore EMD 1214063, in patients with advanced solid tumors who have not responded to previous therapies or f...

Phase II Trial of Neoadjuvant Treatment and Minimal Invasive Surgery for Esophageal and GEJ Cancer

Phase II trial of induction chemotherapy with carboplatin AUC 6 plus paclitaxel 175 mg/m2 in a 21 day cycle for two cycles followed by radiotherapy 4500 cGy in 25 fractions plus carboplati...

PubMed Articles [14307 Associated PubMed Articles listed on BioPortfolio]

How can one optimize induction therapy in AML?

Induction therapy for acute myeloid leukemia has not changed much since 1973, when the 7 + 3 regimen of cytarabine and daunorubicin was born. Since then, various strategies have been evaluated to im...

A pilot study of daunorubicin-augmented hyper-CVAD induction chemotherapy for adults with acute lymphoblastic leukemia.

Induction of complete remission (CR) is imperative for long-term survival in adult acute lymphoblastic leukemia (ALL) patients regardless of transplantation eligibility. Hyper-CVAD chemotherapy is a w...

Chemo-selection with docetaxel, cisplatin and 5-fluorouracil (TPF) regimen followed by radiation therapy or surgery for pharyngeal and laryngeal carcinoma.

Induction chemotherapy for patients with head and neck cancer is widely performed, and several advantages of induction chemotherapy have been reported. However, there is currently insufficient evidenc...

Modified Colistin Regimen for Critically Ill Patients with Acute Renal Impairment and Continuous Renal Replacement Therapy.

Colistin is a last resort antibiotic to treat multidrug-resistant Gram-negative bacteria infections. Colistin is administered intravenously in the form of its inactive prodrug colistin methanesulfonat...

Center practice drives variation in choice of U.S. kidney transplant induction therapy: A retrospective analysis of contemporary practice.

To assess factors that influence the choice of induction regimen in contemporary kidney transplantation, we examined center-identified, national transplant registry data for 166,776 US recipients (200...

Medical and Biotech [MESH] Definitions

Precise and detailed plans for the study of a medical or biomedical problem and/or plans for a regimen of therapy.

The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.

A regimen or plan of physical activities designed and prescribed for specific therapeutic goals. Its purpose is to restore normal musculoskeletal function or to reduce pain caused by diseases or injuries.

A treatment program based on manipulation of the patient's environment by the medical staff. The patient does not participate in planning the treatment regimen.

An acyclic state that resembles PREGNANCY in that there is no ovarian cycle, ESTROUS CYCLE, or MENSTRUAL CYCLE. Unlike pregnancy, there is no EMBRYO IMPLANTATION. Pseudopregnancy can be experimentally induced to form DECIDUOMA in the UTERUS.

More From BioPortfolio on "Study of Systemic and Spinal Chemotherapy Followed by Radiation for Infants With Brain Tumors"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial