DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain Neoplasms; Melanoma

Intervention: Lomustine (Drug); Temozolomide (Drug); Thalidomide (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Nicholas E. Papadopoulos, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Summary

The primary objective of the phase II study is to assess the objective (CR+PR) response rate at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the brain. Secondary objectives include the evaluation of objective response in the extracranial metastases, duration of response and overall survival.

Clinical Details

Official title: A Phase II Study of Temozolomide, Thalidomide, and Lomustine (TTL) in Patients With Metastatic Melanoma in the Brain

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective (CR+PR) response rate

Detailed description: The dosages of Temozolomide and Thalidomide will be fixed, and the dose of Lomustine will be the phase I MTD or the highest dose studied if the MTD was not attained. All 3 drugs will be taken by mouth at home. Each treatment cycle will last for 8 weeks. Temozolomide will be taken once a day for 6 weeks followed by two weeks off. You will take thalidomide every day for the entire 8-week cycle. Thalidomide should also be taken near bedtime, usually 30 to 45 minutes before the temozolomide dose. You will take 2 doses of lomustine every 8 weeks. You will take the first dose of lomustine on Day 1 of the 8-week cycle. You will take the second dose, which will be half as big as the first dose, on Day 29 (the day after the first 4 weeks) of the 8-week cycle. The dose of lomustine is also based on your height and weight. Lomustine should be swallowed and not chewed. A maximum of 30 patients will be enrolled,

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Histologic Documentation: Histologic or cytologic diagnosis of distant metastatic melanoma and clinical evidence of brain metastasis. 2. Pts must have brain lesions of =/> 1. 0cm longest dimension by magnetic resonance (MRI) or spiral computed tomography (CT), if MRI not feasible or > 0. 5cm by MRI with 3D images. Patients with/without extracranial disease are eligible. Measurable extracranial disease is not required. Lesions that are considered non-measurable include: <1. 0 cm by MRI or Spiral CT, Bone lesions, Leptomeningeal disease, Ascites, Pleural/pericardial effusion, Lymphangitis cutis/pulmonis, Abdominal masses that are not confirmed and followed by imaging techniques, Cystic lesions, lesions that are in a previously irradiated area, unless new growth can be documented. 3. Age >/= 18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1 5. No more than 1 prior chemotherapy regimen and no prior chemotherapy for brain metastases. No prior treatment with continuous daily dose of temozolomide; prior immunotherapy and surgical resection are permitted. Patients with prior history of whole brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) are permitted providing that there is measurable lesion with documented growth post radiation or new disease. 6. (#5 continued) Progression of lesions treated with WBRT must be shown by 2 post treatment brain imaging at least 3 weeks apart. Progression of disease is also considered when the patient had increase of lesions as per MRI of brain obtained 4 weeks or more after WBRT completed when compared to baseline MRI obtained less than 1 week prior to start of radiation. Lesions treated with SRS must have responded and then progressed. 7. The following time periods must have elapsed since prior therapy: 3 weeks since surgical resection or stereotactic radiosurgery; 4weeks since prior whole brain radiation therapy; 6 weeks since prior nitrosureas or mitomycin C. Biologic agents used as adjuvants and vaccines or cellular therapies will not require 4-week wash out period if the patient meets all eligibility criteria. 8. No frequent vomiting and/or medical condition that could interfere with oral medication intake (e. g., partial bowel obstruction). 9. No other concurrent chemotherapy/immunotherapy/radiotherapy. 10. No history of active angina or myocardial infarction within 6 months. No history of significant ventricular arrythmia or uncontrolled arrythmia or bradycardia. The study

participants must have resting heart rate of 48 or greater (.e. i - to receive

Thalidomide). 11. No prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE). 12. No known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Because peripheral neuropathies are a common toxicity of antiviral therapy and of viral infection in HIV patients, as well as a common significant toxicity with thalidomide, patients who test positive or who are known to be infected are not eligible. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk. 13. No pre-existing neuropathy that is >/= grade 2, including uncontrolled seizures. 14. No expected need for radiotherapy to brain or any extracranial metastatic site during the period of participation in the study. 15. Patients may not be taking Coumadin, warfarin or heparin products or their derivatives. 16. Patients who require anti-platelet therapy such as daily aspirin, Plavix or ibuprofen are not eligible to participate. 17. Patients requiring the use of bisphosphonates (e. g., zolendronic acid) are not eligible to participate. Patients who receive thalidomide in combination with zolendronic acid are potentially at increased risk of renal dysfunction. 18. Required Initial Laboratory Data: Granulocytes >/= 1,500/ml; Platelet count >/= 100,000/ul; Creatinine

Locations and Contacts

Additional Information

The University of Texas MD Anderson Cancer Center Official Web Site

Starting date: February 2006
Last updated: May 29, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017