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Platinum-based compound

Chemotherapy + Radiation for Brain Cancer

Phase 2

Waitlist Available

Led By Ute K Bartels

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors located in specific locations are eligible

Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR serum creatinine based on age/gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial studies how well chemo + radiation works in treating newly diagnosed brain tumors in young patients.

Who is the study for?

This trial is for young patients with newly diagnosed, localized central nervous system germ cell tumors. Eligible participants include those with specific tumor locations and levels of certain markers in their blood or CSF. They must not have received prior tumor-directed therapy except surgery and corticosteroids, should not be pregnant or breastfeeding, and must agree to use effective contraception if applicable.Check my eligibility

What is being tested?

The study tests the effectiveness of chemotherapy drugs (carboplatin, etoposide, ifosfamide) followed by radiation therapy (either intensity-modulated or 3-dimensional conformal) on younger patients with localized CNS germ cell tumors. The goal is to see if this combination treatment can better eliminate tumor cells without spreading.See study design

What are the potential side effects?

Chemotherapy may cause side effects like nausea, hair loss, fatigue, increased risk of infection due to low blood counts, and potential damage to organs such as kidneys or liver. Radiation therapy might lead to skin irritation at the treatment site, tiredness, headaches depending on the area treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with a specific type of brain tumor.

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My kidney function is normal or near normal.

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My bilirubin levels are within normal range for my age.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy

3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation

Neurocognitive Function Using the ALTE07C1 Protocol

Secondary outcome measures

Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL

Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed

Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL

+1 more

Side effects data

From 2013 Phase 3 trial • 637 Patients • NCT00884741

30%

Fatigue

20%

Thrombosis

20%

Nausea

20%

Hemoglobin decreased

20%

Lymphopenia

20%

Alanine aminotransferase increased

20%

Hyperglycemia

20%

Hyponatremia

20%

Seizure

10%

Alopecia

10%

Weight loss

10%

Opportunistic infection

10%

Dry mouth

10%

Wound infection [with normal or Grade 1-2 ANC]

10%

Wound infection [with unknown ANC]

10%

Wound dehiscence

10%

Vascular access complication

10%

Dysphagia

10%

Acoustic nerve disorder NOS

10%

Anorexia

10%

Dehydration

10%

Eye disorder

10%

Disease progression

10%

Headache

10%

Hearing loss

10%

Tinnitus

10%

Fracture

10%

Creatinine increased

10%

Hyperkalemia

10%

Hypermagnesemia

10%

Hypoalbuminemia

10%

Muscle weakness left-sided

10%

Memory impairment

10%

Neurological disorder NOS

10%

Taste alteration

10%

Depression

10%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Pre-Randomization TMZ+RT

Randomized Arm 1: TMZ+RT + Placebo

Randomized Arm 2: TMZ+RT + Bevacizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy, radiation therapy)Experimental Treatment5 Interventions

See Detailed Description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

2010

Completed Phase 4

~2980

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Etoposide

2010

Completed Phase 3

~2440

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7160

Carboplatin

2014

Completed Phase 3

~6670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,891 Total Patients Enrolled

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,438 Total Patients Enrolled

Ute K BartelsPrincipal InvestigatorChildren's Oncology Group

Media Library

Carboplatin (Platinum-based compound) Clinical Trial Eligibility Overview. Trial Name: NCT01602666 — Phase 2

Central Nervous System Tumor Research Study Groups: Treatment (combination chemotherapy, radiation therapy)

Central Nervous System Tumor Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT01602666 — Phase 2

Carboplatin (Platinum-based compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01602666 — Phase 2

Frequently Asked Questions

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

Is it possible for me to partake in this experiment?

"In order to qualify for this medical trial, applicants must have germinoma and should be between 3-21 years of age. Currently, around 262 participants are needed."

Answered by AI

Does the age requirement for this medical experiment restrict younger individuals?

"To qualify for this trial, applicants must be aged between 3 and 21 years old. According to the available data, there are 390 trials that cater to individuals in the younger age bracket while 1,316 studies focus on seniors."

Answered by AI

How many medical facilities are actively engaged in this research endeavor?

"A total of 100 available slots are open in this research trial, including at Cedars Sinai Medical Center (Los Angeles), Mattel Children's Hospital UCLA (Oakland) and the Children's Hospital and Research Center at Oakland (Sacramento)."

Answered by AI

Could you provide insight into the potential risks associated with Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy is classified as a low risk intervention, which has been assigned a score of 2. This designation takes into account the Phase 2 clinical trial data indicating safety but not efficacy."

Answered by AI

Have extant studies explored the efficacy of Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy was first developed in 1997 at the City of Hope Comprehensive Cancer Center. To date, there are 2102 completed studies and 1537 active trials with many being conducted within Los Angeles, California."

Answered by AI

What primary goals are being pursued with this clinical investigation?

"This 5-year clinical trial is aiming to measure the progression free survival (PFS) rate of those with Central Nervous System Germinoma who were treated with a reduced dose radiation therapy. Secondary objectives include assessing overall survival and PFS in certain demographics, such as patients with Cerebrospinal Fluid hCGbeta levels between 50 mIU/mL and 100 mIU/mL. These results will be evaluated through MRI scans, tumor markers assessments, and Kaplan Meier estimates over three years."

Answered by AI

Are new members currently being enrolled for this research trial?

"Unfortunately, no new participants are being sought for this trial as it was last updated on December 9th 2021. However, if you look around other studies there are currently 64 clinical trials recruiting patients with germinoma and 1,537 seeking enrolment into Intensity-Modulated Radiation Therapy."

Answered by AI

What maladies commonly respond to Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy may be utilized to effectively treat Merkel cell carcinoma, Leukemia and initial treatment."

Answered by AI

What is the current enrollment capacity for this clinical trial?

"This clinical trial has concluded its recruitment process. The posting first went live on May 29th 2012 and was last updated December 9th 2021, so it is no longer open for participants. If you are still looking to join a medical study related to germinoma, there are currently 64 trials actively inviting enrolment; if Intensity-Modulated Radiation Therapy appeals more, 1537 studies are recruiting right now."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase II Trial of Response-based Radiation Therapy for Patients with Localized CNS Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study

Fangusaro, Jason, Shengjie Wu, Shannon MacDonald, Erin Murphy, Dennis Shaw, Ute Bartels, Soumen Khatua, et al.. 2019. “Phase II Trial of Response-based Radiation Therapy for Patients with Localized CNS Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.00701.

clinicaltrials.govStudy

Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

2012. "Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01602666.