Completed

A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain

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What is being tested

temozolomide

+ thalidomide

Drug
Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary I. Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide. Secondary I. Determine the toxic effects of and tolerance to this regimen in these patients. II. Determine the objective response rate in extracranial metastases of patients treated with this regimen. III. Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.

Official TitleA Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain 
NCT00072163
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
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

50 patients to be enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

Inclusion Criteria: * Histologically or cytologically confirmed metastatic melanoma * Clinical evidence of brain metastases * At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI * The following lesions are not considered measurable: * 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 situated in a previously irradiated area, unless new growth is documented * Performance status - CTC 0-1 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Lactic dehydrogenase no greater than 2.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN * Creatinine no greater than 2 mg/dL * No history of active angina * No history of significant ventricular arrhythmia * No history of deep vein thrombosis * No myocardial infarction within the past 6 months * No acute abnormality by EKG * No uncontrolled arrhythmia * No history of pulmonary embolism * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation * No known HIV disease * Thyroid-stimulating hormone normal * Serum anticonvulsant levels normal (for patients on anticonvulsants) * No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake * No preexisting neuropathy greater than grade 1 * No uncontrolled seizures * No other concurrent medical condition that would preclude study participation * At least 4 weeks since prior cytokines * Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period * No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) * No more than 1 prior chemotherapy regimen * No prior chemotherapy for brain metastases * No prior continuous daily temozolomide * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No other concurrent chemotherapy * No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases * See Disease Characteristics * Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion * Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion * At least 4 weeks since prior WBRT * At least 3 weeks since prior stereotactic radiosurgery * No concurrent radiotherapy * At least 3 weeks since prior surgical resection * No concurrent warfarin or heparin products or their derivatives * No concurrent antiplatelet therapy (e.g., daily aspirin, ibuprofen, or clopidogrel bisulfate) * No concurrent bisphosphonates (e.g., zoledronate)

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
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.

Study Objectives

Primary Objectives

Secondary 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

Cancer and Leukemia Group B

Chicago, United StatesSee the location
CompletedOne Study Center