Loading clinical trials...

Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma

A Prospective Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial of Temsirolimus in Combination With Pioglitazone, Etoricoxib and Metronomic Low-dose Trofosfamide Versus Dacarbazine (DTIC) in Patients With Advanced Melanoma

NCT01614301•University of Regensburg

View on ClinicalTrials.gov

Summary

A prospective phase I and consecutive phase II, twoarm, randomized multi-center trial of temsirolimus in combination with pioglitazone, etoricoxib and metronomic low-dose trofosfamide versus dacarbazine (DTIC) in patients with advanced melanoma Phase I: To determine the dose of temsirolimus to be used in phase II part of the study Phase II: To determine overall survival Secondary objectives * To evalulate response rate * To evaluate time to progression (TTP) * To evalulate time to partial response (time to PR or better)(TPR) * To evaluate quality of life * To evaluate tolerability and safety

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age
•Must be able to adhere to the study visit schedule and other protocol requirements.
•Must be histologically diagnosed with metastatic melanoma and LDH level \> 0.8 ULN
•Measurable lesions
•Subjects must receive study medication as first-line therapy. Preceeding adjuvant therapies are allowed.
•BRAF V600 mutation analysis
•Sufficient bone marrow function: neutrophils ≥ 2x109/l, hemoglobin ≥10 g/dl, platelets ≥ 100x109/l
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Post Text Supplement 3).
•Required laboratory results:
•1. Liver function: Total bilirubin \< 1.5 times of upper limit of local institution (ULN), SGPT, SGOT ≤ 2.5 times of upper limit of local institution
+12 more criteria

Exclusion Criteria

•Documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment.
•Patients who require vitamin K antagonists except for low dose
•Patients with bladder cancer or bladder cancer in their medical history, patients with risk factors for bladder cancer (such as exposure to aromatic amines or heavy tobacco smokers), or macrohematuria of unknown origin
•Prior history of stroke
•Known hypersensitivity to study drugs or to any of the excipients
•Active infection \> grade 2 NCI-CTC version 4.0
•Known diagnosis of HIV, hepatitis B, or hepatitis C infection.
•Severe, unstable, or uncontrolled medical disease which would confound diagnoses or evaluations required by the protocol, including cardiac insufficiency (NYHA I -IV) uncontrolled diabetes including diabetic ketoacidosis, chronic hepatic or renal disease, active uncontrolled infection and chronic inflammatory intestinal disease, autoimmune diseases, peripheral arterial disease, verified coronary heart disease, cerebrovascular disease, acute peptic ulcer or acute gastro-intestinal bleeding.
•Prior radiation therapy \> 25% of bone marrow
•Regular blood transfusions
+18 more criteria

Locations (1)

University of Regensburg

Regensburg, Bavaria, Germany

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2016

Last Updated

June 7, 2012

Enrollment

136

ESTIMATED participants

Conditions

Advanced Melanoma

Interventions

dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus

DRUG

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

A Phase II Trial of LM103 in Advanced Melanoma

FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Long-term Follow-up of Checkpoint Inhibitors-induced Ileo-colitis

HS-IT101 Injection in the Treatment of Advanced Melanoma