human stem cell derived neurons

Phase 1 Two Part Dose Escalation Trial of RRx-001 + Radiation + Temozolomide and RRx-001 + Temozolomide Post-RT In Newly Diagnosed Glioblastoma and Anaplastic Gliomas (G-FORCE-1)

 

Summary

This phase I trial will evaluate an experimental intravenous therapy, RRx-001, in combination with standard of care for newly diagnosed patients with high-grade glioma (HGG), including glioblastoma (GBM). Standard of care for newly diagnosed GBM includes radiation therapy and a chemotherapy drug called temozolomide (TMZ).

RRx-001 is thought to act as a radiosensitizer and a chemosensitizer, which means that it may increase the activity of radiation and chemotherapy in tumors. In other ongoing clinical trials, patients have experienced minimal toxicity or side effects with RRx-001 alone and also in combination with radiation in the brain. 

This phase I trial is a two-part dose escalation study to determine whether RRx-001 combines well with radiation therapy and TMZ without adding toxicity in treating patients with newly diagnosed HGG.

Eligible participants will all receive the following:

  • Experimental Group: RRx-001 + Radiation Therapy + TMZ

 

Inclusion Criteria
  1. Histologically proven diagnosis of high-grade glioma, including anaplastic glioma (WHO grade III with 1p/19q chromosomes intact), glioblastoma (WHO grade IV) or gliosarcoma (WHO Grade IV)
  2. The tumor must not have an infratentorial component
  3. The patient must have recovered from the effects of surgery, postoperative infection and other complications before enrollment
  4. Estimated survival of at least 12 weeks
  5. Karnofsky Performance Score of ≥ 70% at the time of entry
  6. Stable or decreasing steroid dose within 2 weeks of first dose of study drug if patient is taking steroids. No steroid use is also acceptable.
  7. Neurological stability for at least 14 days prior to first dose of study drug
  8. Acceptable liver function at screening
  9. Serum creatinine < 1.5x institution upper limit of normal
  10. Acceptable hematologic status at screening
  11. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Exclusion Criteria
  1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years.
  2. Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
  3. Metastases detected below the tentorium or beyond the cranial vault, including tumors with evidence of leptomeningeal metastases as previously indicated
  4. Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
  5. Prior radiotherapy to the head or neck (except for T1 glottic cancer), that would result in overlap of radiation fields
  6. Active connective tissue disorders, such as lupus or scleroderma that in the opinion of the treating physician may put the patient at high risk for radiation toxicity
  7. Unresolved toxicity higher than CTCAE (v. 4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia and hypothyroidism
  8. Acquired immune deficiency syndrome (AIDS) due to the potential for increased complications from treatment; note, however, that HIV testing is not required
  9. No other concurrent chemotherapeutic or investigational agents for this cancer. However, concurrent glucocorticoids are allowed
  10. Inability to swallow pills
  11. Serious co-morbid medical conditions, or a clinically significant laboratory finding(s) or any finding(s) on history and/or examination that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk
  12. Patients who are pregnant or lactating or who are planning to become pregnant during the course of the study are excluded

For the most up-to-date list of criteria, please visit clinicaltrials.gov.

Investigator(s)

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