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Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas | Clinical Trials | Clareo Health

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Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas

A Phase I Study of Oral Carboxyamidotriazole Orotate (CTO) Titrated as a Single Agent in Patients With Advanced or Metastatic Solid Tumors and Titrated in Combination Therapy With Temodar® for Patients With Glioblastoma and Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas

NCT01107522•Tactical Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety, tolerability, and the maximum tolerated dose/recommended phase II dose of carboxyamidotriazole orotate (CTO) as a single agent in patients with advanced or metastatic solid tumors; in combination with oral Temodar® in patients with glioblastoma or other recurrent malignant gliomas; or in combination with oral Temodar® and radiation therapy in patients with newly diagnosed glioblastoma or other malignant gliomas.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must have histologically-confirmed solid tumors that are advanced or metastatic, and refractory after standard therapy, or for which there is no standard therapy.
•2. Patients must have measurable disease as defined by RECIST version 1.1.
•3. Patients must have received prior anticancer therapy or not be eligible for any established conventional therapy whether surgical or pharmacologic.
•4. Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or \<=grade 1 prior to study entry.
•5. Patients must have a performance status of 0, 1, or 2.
•6. Patients must be men and women \>=18 years of age.
•7. Patients must have adequate bone marrow function, defined as an absolute neutrophil count \>=1.5 x 10\^9/L and a platelet count \>= 100 x 10\^9/L.
•8. Patients must have adequate renal function, defined as serum creatinine \<= 1.2 mg/dL (if \> 1.2 mg/dL, a calculated creatinine clearance \[by the Cockcroft-Gault method\] must be \>=60 mL/min/1.73 m\^2).
•9. Patients must have adequate hepatic function, defined as plasma total bilirubin \<=1.5 mg, alanine transaminase (ALT) and aspartate transaminase (AST) \<=2.5 X ULN. Patients with Gilbert's disease outside these limits are judged to be ineligible.
•10. Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
+15 more criteria

Exclusion Criteria

•1. Patients may not have had prior chemotherapy, hormonal therapy, radiation therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study.
•2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
•* Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
•* Active infection.
•* Unstable diabetes mellitus
•* Psychiatric disorder that may interfere with consent and/or protocol compliance.
•3. Pregnant or breastfeeding women.
•4. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does not require further treatment.
•5. Patients with known HIV, HBV, or HCV infection.
•6. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
+32 more criteria

Locations (4)

New York University

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Providence Cancer Center

Portland, Oregon, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

January 1, 2025

Completion Date

January 1, 2026

Last Updated

September 9, 2025

Enrollment

100

ESTIMATED participants

Conditions

Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas

Interventions

CTO

DRUG

CTO and Temodar®

DRUG

CTO, Temodar®, Radiation therapy

DRUG