Proton Radiation For Meningiomas and Hemangiopericytomas

NCT01117844 | Completed Phase 1 DMC

• 1 other identifier: UPCC 24309
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Feasibility/Phase II study for patients with a diagnosis of WHO Grade I - III Meningioma \& Hemangiopericytoma brain cancer to be given standard dose Proton radiotherapy. The study will be performed in two phases: first, feasibility with an enrollment of 12 patients and then Phase Page 8 of 20 II, with an enrollment of an additional 38 patients. All patients will also be given quality of life (QOL) instruments pretreatment, weekly during treatment, then q 3 months for year 1 post treatment, q6 months year 2 \& 3 and yearly for year 4 \& 5. Comparisons will be made between the enrolled subjects receiving proton therapy and the known literature on photon radiation. See section 2 for full objectives. The second phase will begin no earlier than 60 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.

Conditions

Meningioma; Hemangiopericytoma

Outcome Measures

Primary Outcomes (1)

• Feasibility and Safety

  For proton to deemed feasible, no greater than 10% of patients should experience a) Patient cannot be given treatment because anatomy is such that a dosimetically satisfactory treatment plan cannot be devised, b) Patient is unable to tolerate 20% of treatments using proton therapy, and c) patient is unable to complete all treatments within 7 days of estimated date of treatment completion

  90 days

Secondary Outcomes (5)

• Late Toxicity

  90 days

• Fatigue - Brief Fatigue Inventory (BFI)

  5 Years

• Health Related Quality of Life

  5 Years

• Cumulative total dose (Gy) to normal brain tissue

  8 Weeks

• Progression free survival (PFS) and overall survival (OS)

  5 Years

Study Arms (1)

Proton radiation

EXPERIMENTAL

Radiation: Proton Radiation

Interventions

Proton Radiation RADIATION

Protons have been demonstrated for medulloblastoma and prostate cancer, and comparative treatment planning using protons versus photons have shown a clear advantage to protons in terms of dose distribution.

Proton radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of WHO I-III meningiomas and hemangiopericytomas:
• WHO grade I :
• Tumor that are newly diagnosed and tumors that are incompletely excised
• Tumors that have recurred post resection
• WHO grade II:
• Any tumor, either completely or incompletely excised
• Any recurrent tumor
• WHO grade III and hemangiopericytoma:
• Any tumor, either completely or incompletely excised
• Any recurrent tumor
• Patients must have a Karnofsky Performance Status of 60. Age greater than 18 years Patients must be able to provide informed consent.
• Adequate bone marrow function: WBC greater than 4000/mm3, platelets greater than 100,000 mm3.
• Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

You may not qualify if:

• Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma).
• Pregnant women, women planning to become pregnant and women that are nursing. Actively being treated on any other therapeutic research study.
• Prior radiation to the brain.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the Unviersity of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Meningioma; Hemangiopericytoma

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 6, 2010
• Study Start: February 4, 2010
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

US (1)