PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors

NCT00763750 | Completed Phase 2 Results DMC

• 1 other identifier: BrUOG-Brain-223
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the antitumor activity of PPX in combination with temozolomide and radiation for patients with newly diagnosed brain tumors.

Conditions

Brain Tumor

Keywords

glioblastoma multiforme or anaplastic glioma

Outcome Measures

Primary Outcomes (1)

• Number of Patients Assessed for Toxicity According to CTC Version 3.0

  Throughout the entire study until patient is removed from study an average of 6 weeks

Study Arms (1)

PPX +TMZ+XRT

EXPERIMENTAL

XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36

Drug: PPX +TMZ+XRT

Interventions

PPX +TMZ+XRT DRUG

PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)

Also known as: PPX TMZ

PPX +TMZ+XRT

Eligibility Criteria

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

You may qualify if:

• Patients must have histopathologically confirmed, newly diagnosed, glioblastoma multiforme or anaplastic glioma (anaplastic astrocytoma \[AA\], anaplastic oligodendroglioma, and anaplastic oligoastrocytoma) and have not had a complete surgical resection.
• Patients must be 18 years of age or older.
• Patients must have a Zubrod performance status 0-2.
• Patients must not be on enzyme-inducing anti-epileptic drugs (EIAED). Patients may be on non-enzyme inducing anti-epileptic drugs (NEIAED) or may not be taking any anti-epileptic drugs.
• Patients must not have received prior chemotherapy, radiation or any experimental therapy for their glioblastoma.
• Patients may not be breast-feeding a child.
• Female patients must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Female patients must be using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR female patients must be at least 1-year post-menopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy. Male patients must be surgically sterile or using an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner
• Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast. Patients with prior malignancies must be disease-free for ≥ 2 years.
• Patients must have normal organ and marrow function as defined below:
• Absolute neutrophil count \> 1,500/ul
• Platelets \> 100,000/ul
• Hemoglobin \> 8 gm/dL
• Total bilirubin \< 1.5 x ULN
• Creatinine \< 1.5 x ULN

You may not qualify if:

• Recurrent malignant gliomas.
• Tumor foci detected below the tentorium or beyond the cranial vault.
• Allergy to gadolinium or contraindication to MRI scan.
• Patients who have received any form of brachytherapy or radiosurgery for their glioblastoma prior to start of standard radiation.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PPX.
• Uncontrolled intercurrent illness including, but not limited to, hypertension ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with PPX, breastfeeding should be discontinued if the mother is treated with PPX.

Sponsors & Collaborators

• howard safran: lead
• Rhode Island Hospital: collaborator
• MaineHealth: collaborator

Study Sites (1)

Lifespan Hospitals

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

Hsafran@lifespan.org

4018633000

Study Officials

• Howard Safran, MD

  BrUOG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 1, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: February 17, 2020
• Results First Posted: December 16, 2013

Record last verified: 2020-02

Locations

US (1)