Val trial

See more conditions. Clinical Trials. Find trials By condition, treatment or drug name Search tips. Overview Participation eligibility Participating Mayo Clinic info More information Additional contact information Cancer-related trials contact form Phone: toll-free International patient clinical studies questions Phone: Email: intl. Study type Interventional. Study phase 3. Study IDs. Agree to allow the sponsor to collect data on all GBM-related treatments received after the patient comes off the current study, and to collect survival data after the patient comes off the current study.

Histologically confirmed initial diagnosis of primary glioblastoma multiforme GBM or gliosarcoma GS , now recurrent. Patients with prior low-grade glioma or anaplastic glioma are eligible, if histologic assessment demonstrates transformation to GBM or GS. Adequate recovery from all recent surgery is required; at least 1 week must have elapsed from the time of a minor surgery; at least 21 days must have elapsed from the time of a major surgery.

Patients must have recovered from all surgery-related toxicities to Grade 1 or less. Greater than 12 weeks from radiotherapy, to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as pseudoprogression of disease, unless the recurrence is a new lesion, outside the primary radiation field or the patient fulfills criteria for early progressive disease by RANO Wen et al.

Prior therapy with gamma knife or other focal high-dose radiation is allowed, but at least 2 weeks must have elapsed from the time of treatment, and the patient must have subsequent post-radiotherapy histologic documentation of recurrence in the irradiated field, unless the recurrence is a new lesion outside the irradiated field.

At least 28 days or 5 half-lives whichever is shorter since prior investigational anti-cancer drugs. A minimum of 21 days between termination of the investigational drug and administration of VAL is required.

Must have recovered from all treatment-related toxicities to Grade 1 or less. A declining KPS is defined by reduction of 10 points or more over at least a day period.

Patient must have a predicted life expectancy of at least 12 weeks. QTc No clinically significant cardiac conduction disorder on screening. Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to planned first dose of treatment, and agree to use dual method of contraception through 90 days after study drug treatment.

Approved methods of contraception include an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner.

If male, patient must be sterile or willing to use an approved method of contraception from the time of Informed Consent to 90 days after study drug treatment.

Physical Therapy and Human Movement Sciences. Overview Fingerprint. Access to Document Link to publication in Scopus. Link to the citations in Scopus. Together they form a unique fingerprint.

View full fingerprint. PloS one , 5 8 , [e]. Swoboda, Kathryn J. In: PloS one. In: PloS one , Vol. Current history of neoplasm other than the entry diagnosis.

Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the Sponsor. Evidence of leptomeningeal spread of disease. Need for urgent palliative intervention e. Patients with a known sensitivity to any of the products to be administered during treatment. Patients unable to undergo MRI of the brain. Women who are pregnant or lactating. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment.

Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. Each participating trial investigator will be provided a copy their patient data captured in the electronic data base for this trial. Layout table for additional information Studies a U. Glioma Glioblastoma Glioblastoma multiforme GBM brain tumor brain cancer recurrent brain tumor recurrent brain cancer refractory brain tumor refractory brain cancer recurrent GBM refractory GBM recurrent glioma refractory glioma recurrent glioblastoma refractory glioblastoma recurrent glioblastoma multiforme refractory glioblastoma multiforme failed bevacizumab temodar failure temozolomide failure adjuvant therapy.

National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: VAL, Dianhydrogalactitol. Phase 2. Study Type :.

Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :.

Estimated Study Completion Date :. Experimental: VAL, Dianhydrogalactitol Group 2 Newly diagnosed GBM patients who have completed chemoradiation treatment with temozolomide and received no subsequent maintenance temozolomide.

March 24, Key Record Dates. The Clinical Study Report for this trial will be prepared and provided to U.