Completed

Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma

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What is being tested

temozolomide

+ thalidomide
Drug
Who is being recruted

Recurrent Melanoma

+ Stage IV Melanoma
+ Tumors Metastatic to Brain
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 17, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells 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 
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 17, 2013
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 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, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

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

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

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.
Over 18 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
Recurrent Melanoma
Stage IV Melanoma
Tumors Metastatic to Brain
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

90% confidence intervals will be used.
Secondary Objectives

Kaplan-Meier method will be used.

Kaplan-Meier method will be used.

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 BChicago, United StatesSee the location

CompletedOne Study Center