Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Glioma

Astrocytoma

Oligodendroglioma

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Anticonvulsants

Receive study drug for three consecutive days, Cycle repeated every 21 days.

Receive study drug once a week for four consecutive weeks. Repeat cycle every 5 weeks.

Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.

RTA 744

Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.

RTA 744 injection

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.

Malignant gliomas, glioblastoma multiforme and anaplastic astrocytoma, are rapidly growing primary brain tumors associated with a high degree of morbidity and mortality. Despite aggressive treatment, the median survival rate for GBM is approximately 12 months, with two-year survival rates no more than 8 to 12%, while median survival for patients with AA ranges from 2 to 3 years from time of first diagnosis.

RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin. Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. It will be administered by i.v. infusions either daily for 3 consecutive days repeated every three weeks, or once weekly for 4 consecutive weeks repeated every 5 weeks. Once the maximum tolerated dose is determined , a new group of patients will be enrolled into the study to evaluate the tolerability and MTD when administered on an expanded schedule (once a week).

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas

A Phase I Dose-finding and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent or Refractory Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Anaplastic Mixed Oligo-astrocytoma (AOA), Glioblastoma Multiforme (GBM) or Gliosarcoma (GS), With or Without Concurrent Treatment With Enzyme-inducing Anticonvulsant Therapy

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Reata, a wholly owned subsidiary of Biogen

Nervous System Diseases

Meningeal Carcinomatosis

Meningitis

Carcinoma

Neuroinflammatory Diseases

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

RTA 744 injection administered intravenously for a maximum of 18 cycles (54 weeks). Dose escalation based on four dose levels and occurance of dose limiting toxicity (DLT).

Aqueous solution of RTA 744 is packaged in 5 ml vials - 1 mg/ ml. The drug is mixed in D10W and infused over 2 hours on three consecutive days.

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent neoplastic meningitis.

Neoplastic meningitis refers to the deposition of malignant cells in the lining (leptomeninges) of the brain and spine. Neoplastic meningitis from solid tumors most often occurs in patients with advanced systemic disease who have failed prior chemotherapy; it is also frequent in patients with CNS parenchymal metastasis. Patient survival remains low, and better treatments are needed to penetrate the blood brain barrier and treat the entire neuraxis.

RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin. Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. Dose escalation will continue as pre-determined until first occurrence of a dose-limiting toxicity. Maximum tolerated dose will be determined as defined in protocol.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis

A Phase I Safety and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent, Progressive or Refractory Neoplastic Meningitis

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Leukemia

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Lymphosarcoma

4.8 mg/m\^2 by vein Over 2 Hours On Days 1-3.

Morris D. Groves, MD

1. The primary objectives of this study are:

   1. To determine the tolerability of RTA 744 Injection in patients with leptomeningeal disease (LMD) secondary to any type of primary tumor.
   2. In a selected group of 6-10 patients who will receive RTA 744 at or near the maximum tolerated dose (MTD), to characterize the multiple-dose pharmacokinetics of RTA 744 in plasma and CSF.
2. The secondary objectives of this study are:

   1. To document any potential antitumor activity of RTA 744 in this patient population.
   2. To correlate pharmacokinetic information with clinical (efficacy and safety) responses, as a possible help in selecting appropriate doses for later studies.

RTA 744 is designed to enter the spinal fluid and kill cancer cells both in the spinal fluid and in the rest of body.

Before you can start receiving the study drug, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will be asked about any drugs you have taken and are taking. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). You will have a neurological exam. Blood (about 2 tablespoons) will be drawn for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative. Urine will be collected over a 24-hour period to test kidney function and for routine tests. You will have a magnetic resonance imaging (MRI) scan of the brain and spine.

You will have a chest x-ray. You will be asked questions about your ability to perform daily activities (performance status evaluation). You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). You will have either a multiple gated acquisition scan (MUGA) or an echocardiogram to check your heart's health. Samples (1 1/2 teaspoons) of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells. The spinal sample will be collected through a lumbar puncture (spinal tap). The other sample will be taken from your brain through an Ommaya Reservoir tap. Radioactive dye will be injected into the CSF to make sure the CSF flows freely throughout the spinal canal. This is called an Indium-111 DPTA or Technetium 99m-DPTA Flow Study.

If you are found to be eligible to take part in this study, you should receive the same dose of RTA 744 throughout the study. The amount of study drug you receive will be determined by when you begin the study. Every 21 days on study is considered 1 study "cycle." If you have intolerable side effects, the drug dosing for the next cycle may be delayed for up to 21 days to allow any symptoms or side effects to resolve. You may be given a lower dose level.

The first participant on this study will receive the dose that has been found to be well-tolerated in an ongoing study involving participants with primary brain tumors. After this participant has completed 1 study cycle, the next participant will be given a higher dose of RTA 744. Each new participant will receive a higher dose level until a patient has an intolerable side effect. When this happens, at least 2 more participants will be given the dose level that causes the intolerable side effect. If there are no further intolerable side effects to RTA 744, the next group of 3 participants will be given the next higher dose of RTA 744. Each time, the dose of RTA 744 will not be increased until the effects of the previous dose level have been studied. Doses will increase with each group of patients until the highest tolerable dose is found.

On Day 1 Cycle 1, before you receive the first dose of RTA 744, you will have a physical exam, neurological exam, and a performance status evaluation. If the screening neurological exam was performed less than 1 week before Day 1, the neurological exam will not need to be repeated. You will also be asked about any drugs, treatments, or herbal medicines you are taking. You will be asked how you are feeling and if whether you are experiencing any symptoms or side effects. Blood (less than 2 tablespoons) and urine will be collected for routine tests, unless blood and urine were collected for screening within the past 72 hours.

After completion of these tests, you will receive RTA 744 through a needle in your vein over a 2-hour period on Days 1-3. You must remain in the clinic for 2 hours after the drug is given to make sure you are not having any side effects.

During Cycle 1, you will be asked to return to the clinic once a week for 3 weeks. At these visits, blood (less than 2 tablespoons) will be drawn for routine tests. You will be asked how you are feeling and whether you are having any side effects.

On Day 21, you will have a neurologic exam.

Before receiving the study drug on Day 1 of Cycles 2-18, you will have a physical exam, neurological exam, and a performance status evaluation. You will also be asked about any drugs, treatments, or herbal medicines you are taking. Blood (less than 2 tablespoons) and urine will be collected for routine tests. You will have an ECG. Before Cycles 4, 6, 8, 10, 12, 14,16, and 18, you will have a MUGA scan or an echocardiogram. Once you have completed the tests, you will receive the study drug in the same manner as Cycle 1.

During Days 1-3, you will be asked how you are feeling and to report any symptoms or side effects you may have noticed during or after receiving RTA 744.

On Day 15, blood (about 3 teaspoons) will be drawn for routine tests. This blood draw may be performed by an outside laboratory. If no clinic visit is scheduled on Day 15, you will be contacted by telephone to find out if you have experienced any side effects. This phone call should last less than 5 minutes.

On Day 21, blood (less than 2 tablespoons) will be drawn for routine tests.

One time (per cycle) between Day 15 and Day 21 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, and 18, a sample (about 2 teaspoon each time) of CSF will be collected from your spine through a spinal tap, and from your brain through an Ommaya Reservoir tap. This will be done in order to look for cancer cells. You will also have an MRI of the brain and spine.

An ECG will be performed during the last week of all cycles. A MUGA scan or an echocardiogram will be performed during the last week of Cycles 4, 6, 8, 10, 12, 14, 16, and 18.

You will have an MRI within 1 week of the end of the last cycle.

You may remain on study for up to 18 cycles (13 months). You will be taken off study if the disease gets worse or intolerable side effects occur.

Once you are off study, you will have an end-of-study visit. At this visit, your complete medical history will be recorded. You will be asked about any drugs you have taken and are taking. You will have a physical exam, including measurement of vital signs. You will have a neurological exam. Blood (about 2 tablespoons) will be drawn for routine tests. Urine will be collected over a 24-hour period to test kidney function and for routine tests. You will have an MRI of the brain and spine.

You will have a chest x-ray. You will have a performance status evaluation. You will have ECG and MUGA scans or echocardiogram. Samples (1 1/2 teaspoons each) of cerebrospinal fluid from your spine and brain will be collected to look for the presence of cancer cells. The spinal sample will be collected through a spinal tap. The other sample will be taken from your brain through an Ommaya Reservoir tap. Radioactive dye will also be injected into the CSF to make sure the CSF flows freely throughout the spinal canal.

THIS IS AN INVESTIGATIONAL STUDY. RTA 744 is not FDA approved or commercially available. It has been authorized for use in research only.

Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas	NCT00526812	Glioma	RTA 744 RTA 744 injecti...	18 Years -	Biogen
A Safety Study of RTA 744 in Recurrent, Progressive or Refractory Neoplastic Meningitis	NCT00527410	Leptomeningeal ...	RTA 744	18 Years -	Biogen
RTA 744 Injection in Patients With Leptomeningeal Disease	NCT00512460	Neoplastic Meni... Solid Tumor Lymphoma Leukemia Brain Tumor	RTA 744	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for rta 744

Every month we try and update this database with for rta 744 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rta 744

Every month we try and update this database with for rta 744 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rta 744 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.