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Radiation Therapy for Cutaneous Granular Cell Tumor

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Cutaneous Granular Cell Tumor+35 More ConditionsRadiation Therapy - Radiation
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the combination of pazopanib, chemotherapy, and radiation therapy or radiation therapy alone to treat patients with non-rhabdomyosarcoma soft tissue sarcomas.

Eligible Conditions
  • Malignant Cutaneous Granular Cell Tumor
  • Plexiform Fibrohistiocytic Tumor
  • Sclerosing Epithelioid Fibrosarcoma
  • Undifferentiated High Grade Pleomorphic Sarcoma of Bone
  • Liver Embryonal Sarcoma
  • Low Grade Fibromyxoid Sarcoma
  • Malignant Peripheral Nerve Sheath Tumor
  • Extra Skeletal Myxoid Chondrosarcoma
  • Fibrohistiocytic Neoplasm
  • Alveolar Soft Part Sarcoma
  • Angiomatoid Fibrous Histiocytoma
  • Atypical Fibroxanthoma
  • Clear Cell Sarcoma of Soft Tissue
  • Extraskeletal Osteosarcoma
  • Inflammatory Myofibroblastic Tumor
  • Intimal Sarcoma
  • Myxofibrosarcoma
  • Myxoid Chondrosarcoma
  • Myxoinflammatory Fibroblastic Sarcoma
  • Synovial Sarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Low Grade Myofibroblastic Sarcoma
  • Malignant Triton Tumor
  • Chondrosarcoma
  • PEComas
  • Pericytic Neoplasm
  • Fibrosarcoma
  • Nerve Sheath Tumors
  • Skin Glomus Tumor
  • Epithelioid Sarcoma
  • Stage IIB Soft Tissue Sarcoma
  • Stage III Soft Tissue Sarcoma
  • Stage IB Soft Tissue Sarcoma
  • Stage IV Soft Tissue Sarcoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

Similar Trials

1
MGC018
1
Healthy Controls
1
KITE-222

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: From enrollment up to 60 months

Week 6
Feasible Dose: Adult
Feasible Dose: Pediatric
At diagnosis
Prevalence of Circulating Tumor DNA (ctDNA)
Relative Frequency of Actionable Mutations
Month 60
Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
Percentage of Patients Local Failure Free at 5 Years Following Study Entry
Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
Week 10
Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax)
Month 60
Relative Risk of Failure Based on Both Standard Imaging and Pathologic Assessment
Year 1
Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Hour 48
Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib
Week 10 after induction
Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
Week 13 after induction
Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
MGC018
1
Healthy Controls
1
KITE-222

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4 Treatment Groups

Regimen A (pazopanib, chemoradiation)
1 of 4
Regimen B (chemoradiation)
1 of 4
Regimen C (pazopanib, radiation therapy)
1 of 4
Regimen D (radiation therapy)
1 of 4

Experimental Treatment

140 Total Participants · 4 Treatment Groups

Primary Treatment: Radiation Therapy · No Placebo Group · Phase 2 & 3

Regimen A (pazopanib, chemoradiation)Experimental Group · 7 Interventions: Pazopanib, Pazopanib Hydrochloride, Radiation Therapy, Doxorubicin Hydrochloride, Ifosfamide, Therapeutic Conventional Surgery, Doxorubicin · Intervention Types: Drug, Drug, Radiation, Drug, Drug, Procedure, Drug
Regimen B (chemoradiation)Experimental Group · 5 Interventions: Radiation Therapy, Doxorubicin Hydrochloride, Ifosfamide, Therapeutic Conventional Surgery, Doxorubicin · Intervention Types: Radiation, Drug, Drug, Procedure, Drug
Regimen C (pazopanib, radiation therapy)Experimental Group · 4 Interventions: Pazopanib, Pazopanib Hydrochloride, Radiation Therapy, Therapeutic Conventional Surgery · Intervention Types: Drug, Drug, Radiation, Procedure
Regimen D (radiation therapy)Experimental Group · 2 Interventions: Radiation Therapy, Therapeutic Conventional Surgery · Intervention Types: Radiation, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pazopanib
FDA approved
Pazopanib
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7360
Doxorubicin
FDA approved
Ifosfamide
FDA approved
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from enrollment up to 60 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,275 Previous Clinical Trials
41,234,672 Total Patients Enrolled
Aaron R WeissPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This study involves examining both your arms (including shoulders) and legs (including hips).
This criterion is unclear and needs more information to provide a simplified explanation. Can you please provide more context or details?

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
What state do they live in?
Colorado100.0%
How many prior treatments have patients received?
3+100.0%
References

Frequently Asked Questions

Do we have any previous data to compare the results of this trial to?

"Clinical research for Radiation Therapy began in 1997. The first study was completed that year and was sponsored by Alfacell. After the Phase 3 approval was granted, following the first trial's completion, the number of active trials for this intervention has grown to 1099. They are being conducted across 74 different nations and in 2321 unique cities." - Anonymous Online Contributor

Unverified Answer

Are there different research hospitals testing this new treatment in town?

"This clinical trial is being hosted at Stanford Cancer Institute Palo Alto in Palo Alto, California, Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center in Denver, Colorado, and Saint Joseph's Hospital/Children's Hospital-Tampa in Tampa, Florida. 100 other locations are also participating." - Anonymous Online Contributor

Unverified Answer

What are the goals that this experiment seeks to achieve?

"The primary outcome of this study is to assess the feasibility of a pediatric dose of the medication. This will be evaluated over a 6-week induction period. Secondary outcomes include the percentage of patients who are local failure-free at 5 years following study entry, the percentage of patients who are regional failure-free at 5 years following study entry, and the percentage of patients who experience Grade 3 or higher toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)." - Anonymous Online Contributor

Unverified Answer

What are some of the most popular reasons people choose to go through Radiation Therapy?

"Radiation therapy is often used as a treatment for small cell lung cancer, but it can also ameliorate symptoms for patients with leukemia, myelocytic, acute, multiple sclerosis, lymphoma." - Anonymous Online Contributor

Unverified Answer

What does the research say about the effectiveness of Radiation Therapy?

"The first recorded study of radiation therapy was at Spectrum Health Hospital - Butterworth Campus in 1997. As of now, there have been a total of 1799 completed trials. Out of the 1099 ongoing studies, many are based in Palo Alto, California." - Anonymous Online Contributor

Unverified Answer

What is the target recruitment number for this research project?

"This specific study is no longer looking for participants, as it was first posted on 7/11/2014 and last updated on 10/18/2022. However, there are presently 2925 other trials involving pecomas and 1099 Radiation Therapy trials that are actively enrolling patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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