Completed

TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

TAC-101

Drug
Who is being recruted

Liver Cancer

From 18 to 80 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2001

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: October 31, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2001Actual date on which the first participant was enrolled.

RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer). OBJECTIVES: Phase I * Primary * Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma. * Determine the safety of 2 consecutive courses of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine the toxic and adverse effects profile of this drug in these patients. Phase II * Primary * Determine the objective antitumor response rate in patients treated with this drug at the MTD. * Secondary * Determine the overall survival time of patients treated with this drug. * Determine the time to disease progression in patients treated with this drug. * Determine the duration of observed objective response, using WHO criteria and measurements of serum alpha-fetoprotein concentrations, in patients treated with this drug. * Determine the time to treatment failure in patients treated with this drug. * Determine the safety and tolerability of intermittent treatment with this drug in these patients. OUTLINE: This is an open-label, dose-escalation study. * Phase I: Patients receive oral TAC-101 once daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive oral TAC-101 at the MTD (determined in phase I) once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 35-60 days. PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.

Official TitlePhase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma 
Principal SponsorM.D. Anderson Cancer Center
Last updated: October 31, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
37 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Liver Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatocellular carcinoma * At least 1 previously unirradiated, bidimensionally measurable lesion greater than 20 mm by MRI or conventional CT scan OR at least 10 mm by spiral CT scan * Patients with CNS involvement must have completed appropriate treatment and have no progressive neurologic deficits within the past 28 days * No carcinomatous meningitis PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-2 Life expectancy * More than 12 weeks Hematopoietic * Hemoglobin ≥ 10.0 g/dL * WBC ≥ 2,000/mm\^3 * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 40,000/mm\^3 * No abnormal bleeding or clotting Hepatic * No grade C Child-Pugh cirrhosis * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Albumin ≥ 2.8 g/dL * INR ≤ 1.5 times ULN * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No prior deep vein thrombosis * No prior superficial venous thrombosis * No family history of thromboembolism in a first-degree relative * No lower extremity thromboses by Doppler ultrasound (unless a subsequent venous angiography confirms a false positive ultrasound) Pulmonary * No prior pulmonary embolism Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception, except oral contraceptives containing estrogen * Fasting triglycerides ≤ 400 mg/dL for men or ≤ 325 mg/dL for women * No other malignancy within the past 3 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix * No uncontrolled metabolic disorders, other nonmalignant organ or systemic disease, or secondary effects of cancer that induce a high medical risk * No known allergy or hypersensitivity to TAC-101 or its components PRIOR CONCURRENT THERAPY: Biologic therapy * No prior thalidomide * No prior putative antiangiogenesis therapy * Prior interferon allowed Chemotherapy * No more than 2 prior chemotherapy regimens Endocrine therapy * No concurrent estrogen products Radiotherapy * See Disease Characteristics * More than 21 days since prior radiotherapy, except small portal radiotherapy used for the palliation of isolated, symptomatic, osseous metastases * No prior radiotherapy to evaluable lesions * No concurrent radiotherapy unless for bone pain that is present before beginning study Surgery * Not specified Other * Prior anticancer treatment allowed provided there is clear evidence of progressive disease after the most recent treatment * More than 21 days since prior anticancer therapy and recovered * No more than 2 prior treatment regimens * No concurrent therapeutic anticoagulants * Concurrent low-dose warfarin for prophylactic care of indwelling venous access devices allowed * No concurrent azoles or tetracyclines * No concurrent medications known or suspected to increase risk of venous thromboembolism * No other concurrent retinoids


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
MD Anderson Cancer Center at University of TexasHouston, United StatesSee the location

CompletedOne Study Center