Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Rare Diseases

Neoplasm Metastasis

Melanoma

Brain Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Temozolomide

Lomustine

Thalidomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Lomustine starting dose 30 mg/m\^2 by mouth daily on Day 1 and 29. Temozolomide 75 mg/m\^2 by mouth daily on Days 1 to 42. Thalidomide 200 mg/m\^2 by mouth daily.

Starting dose 30 mg/m\^2 by mouth daily on Day 1 and 29.

75 mg/m\^2 by mouth daily on Days 1 to 42.

Nicholas E. Papadopoulos, MD

The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU, CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM) in the treatment of metastatic melanoma that has spread to the brain. The safety and effectiveness of this combination therapy will also be studied.

Temozolomide works by blocking a tumor cell's ability to grow. Lomustine is also a chemotherapy drug that works by killing tumor cells. Studies have shown that when lomustine and temozolomide are given together, they decrease the amount of a certain protein, allowing the tumor cells to be more easily killed. Thalidomide is a drug that alters the immune system. it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.

If you are found to be eligible to take part in this study, you will begin treatment. All 3 drugs will be taken by mouth at home. Each treatment cycle will last for 8 weeks. You will take temozolomide once a day for 6 weeks followed by two weeks off. The best time to take temozolomide is around bedtime, since you must not eat for at least 1 hour before and 1 hour after taking it. The number of capsules you will take is based on your height and weight. You must swallow all the temozolomide capsules at the same time with 8 ounces of water (do not chew them).

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. If you are under 70 years of age, you will start at a set dose and take the same dose throughout the study. If you are age 70 or over, the dose will start lower and will increase every 2 weeks until you are taking the prearranged set dose that those under the age of 70 are taking. Your doctor will be watching for side effects as the dose increases and may keep you at a lower dose if necessary.

In the first groups of patients (3-6 patients per group, total up to 18 patients) to be enrolled, each new group of participants will be given a higher dose of lomustine than the previous group until the highest safe dose of lomustine is found or until 18 patients have been enrolled. Responses to these doses will be evaluated. Once the best dose is found, all future participants will receive that dose of lomustine.

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.

During treatment, every 2-4 weeks, you will have a complete physical exam and blood drawn for testing (1-2 tablespoons). These tests will let the doctor know if the treatment should be changed, briefly interrupted, or stopped. Women who are able to have children must have a negative pregnancy test every week for the first 4 weeks if they have regular menstruation and every 2 weeks if their periods are irregular.

At the end of 8 weeks, you will have x-rays or scans done again to see how the tumors have responded. If they are the same size or have gotten smaller, you may continue the treatment. You may stay on treatment as long as you are not having severe side effects and your tumor is either staying the same size or getting smaller. Treatment will be stopped if the tumors are getting bigger.

If you are withdrawn from the study for any reason you will be contacted by phone every three months to learn how are you doing health wise.

This is an investigational study. None of the 3 drugs used in this study have been approved by the FDA for the treatment of melanoma. Temozolomide has been approved for the treatment of brain cancer. Thalidomide has not yet been approved for the treatment of cancer. Lomustine is approved for the treatment of brain tumors and Hodgkin's disease. All of the drugs are commercially available. Their use together in this study is experimental.

Up to 18 patients will take part in this Phase I portion of the study, and another 30 patients in Phase II if progresses, with up to 48 patients total. All will be enrolled at M. D. Anderson.

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

A Phase I Study of Temozolomide, Thalidomide, and Lomustine (TTL) in Patients With Metastatic Melanoma in the Brain

Celgene Corporation

M.D. Anderson Cancer Center

Analgesics

Aldesleukin

Cisplatin

Vinblastine

Interferons

Interleukin-2

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Analgesics, Non-Narcotic

Tubulin Modulators

Antimitotic Agents

Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.

250 mg/m\^2 By Mouth Every 4 Hours x 3 Doses On Day 1

1.5 mg/m\^2 By Vein Over 15-30 Minutes On Days 1-4

Velban

20 mg/m\^2 By Vein Over 45-120 Minutes On Days 1-4

9 MIU/m\^2 By Vein Over 24 Hours x 4 Doses On Days 1-4

5 mu/m\^2 Subcutaneously (Under the skin) Daily On Days 1-5

Intron-A

The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.

Some of the drugs in this study have been used with DTIC (Dacarbazine) in the past to control Melanoma that has spread to other parts of the body. However, in most of those cases, the duration of these results are limited and ineffective to control or prevent spread of the disease into the brain, the membranes that cover the brain, the spinal cord, and the nerve roots. In this study, temozolomide is being used instead of DTIC. Temodar has been proven to be one of the most effective therapeutic agents to control malignancies in the brain. Thalidomide is designed to decrease the formation of new blood vessels that feed tumors.

The treatment plan for this study is divided in two parts. The first part of this study (induction therapy) is done to try to get your disease under control. The second part of this study (maintenance therapy) is to maintain or improve the results of the first part of the treatment plan.

Induction Therapy:

Induction therapy includes three 5-day courses of treatment with thalidomide, temozolomide, vinblastine, cisplatin, interleukin-2, and interferon-alpha. The courses are repeated in cycles of three to four weeks depending on recovery from side effects from the previous course of treatment.

All of the drugs that are given through a vein will be given through a catheter (plastic tube) inserted in a vein in one of your arms or into the vein that runs underneath the collar bone and threaded into the central vein in the upper part of the chest.

You will be admitted in the hospital on Day 0. You will start receiving liquids (hydration) and be prepared to start temozolomide on day 1 of the admission. It is anticipated that you will remain in the hospital for one week. Depending on degree of side effects a longer stay in the hospital may be required.

Temozolomide will be given by mouth on the first day of the treatment every 4 hours for three doses. A fourth dose may be considered with later courses of treatment if it is well tolerated.

Vinblastine will be given through the catheter on Days 1,2,3 and 4 of the cycle. The infusion should last between 15 to 30 minutes.

Cisplatin will be given through the catheter on Days 1,2,3 and 4 of the cycle. The infusion should last between 45 to 120 minutes. Care will be given to fully hydrate the body to decrease chances for kidney damage.

Thalidomide will be given by mouth once a day throughout the cycle of treatment. It is given as a single dose starting on Day 0, the day before the start of the temozolomide, and then every day for the entire cycle.

Interleukin-2 will be given as continuous infusion through the catheter over 24 hours for four days in a row (over 96 hours). It will be given from Day 1 through Day 5 of the cycle.

Interferon alpha will be given as "an insulin-type injection" under the skin, into the fatty tissue, once a day on Days 1,2,3,4 and 5 of each cycle

You will receive up to 3 courses of induction therapy. The courses will be repeated in cycles of 3-4 weeks depending on adequate recovery from the side effects. If you have stable disease or improved disease, you will go on to receive maintenance therapy.

Maintenance Therapy:

Long-term daily treatment with the study drugs will be given for six 4-week cycles.

Temozolomide will be given by mouth daily for 21 days (3 weeks). This will be followed by one week without Temozolomide treatment. This makes up one cycle of treatment.

Interleukin-2 and interferon alpha will be given during the one week of rest from temozolomide. This will require one week of hospitalization. Interleukin-2 is given as a continuous infusion through the catheter over the first 5 days. The first day the dose will be high and it will be decreased slowly to a lower dose on the last 3 days. The interferon alpha will be given as an injection in the fatty tissues under the skin once a day for 5 days on the same days the interleukin-2 is given.

Thalidomide will be given by mouth once a day every day for the full 4-week cycle.

Supportive care with medications for fever, chills, nausea, vomiting, diarrhea, will be given during treatment. You will also be given fluids with appropriate electrolytes to replenish blood levels and to replenish blood volume to help the kidneys.

How you respond to treatment will be evaluated with computed tomography (CT) scans and magnetic resonance images (MRIs) of the brain. This will occur after the second course and third course of induction therapy and then after the third and sixth courses of maintenance therapy and periodically until off study.

You will be requested to complete a questionnaire to evaluate your quality of life before treatment starts, at the end of Cycles 2 and 3 of induction therapy, and at the end of Cycles 3 and 6 of maintenance therapy.

You will be taken off study if the disease gets worse or intolerable side effects occur. Should you be taken off study early, a long term follow-up will be requested.

For those patients who complete the treatment, radiographic evaluation with body CT scans and brain MRI will be done. They will have physical exams, and blood tests (1 to 2 tablespoons per visit) every 3 months for the first year, every 4 months for the second year, every 6 months up to the 5th year, and then once a year.

A total of 60 patients will take part in this study.

Biochemotherapy With Temozolomide for Metastatic Melanoma

Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment

TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).

Biochemotherapy With Temozolomide

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Nicholas E. Papadopoulos, MD / Professor

Time to Progression (TTP)

Number of Participants With Response

Overall Study

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Disease Progression

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lenalidomide

Thalidomide 100 mg by mouth daily for 28 days in a 28 day cycle started after the clinical documentation of biochemical progression.

Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.

100 mg by mouth daily for 28 days in a 28 day cycle.

Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.

Questionnaire completion at screening, once a month for the first 6 months, then every other month while on study.

Questionnaires

Qaiser Bashir, MD

The goal of this clinical research study is to learn if adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will begin taking lenalidomide and thalidomide by mouth once a day, in the evening. Thalidomide should be taken at least 1 hour after your evening meal. Bedtime is the best time to take thalidomide.

Swallow the lenalidomide and thalidomide capsules whole with at least 4 ounces of water. Do not open, crush, or break the lenalidomide or thalidomide capsules. If you touch a broken lenalidomide or thalidomide capsule, wash the affected area of your body with soap and water.

If you miss a dose of lenalidomide and/or thalidomide, and it has been less than 12 hours since your regular dosing time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.

If you take too much lenalidomide and/or thalidomide (overdose), call your primary healthcare provider or poison control center right away.

If you vomit after taking your dose, you should wait to take another dose until the next scheduled time.

You will be given a patient study drug diary. You will use this diary to write down what time you took each dose of lenalidomide and thalidomide. You need to bring the study drug diary to every study visit so the study staff can review it.

Since lenalidomide and thalidomide both increase the risk of developing blood clots, especially in patients who are at high risk or with a history of blood clots, you may receive heparin, warfarin, or aspirin to help prevent blood clots. Your doctor will decide which medication you need, or your doctor may decide that you do not need a medication to help prevent blood clots, based on your platelet count (cells that help your blood clot).

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

Once a month for the first 6 months:

* You will have a physical exam.
* You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes). You will be asked about any numbness or tingling you may be experiencing.
* Blood (about 2 tablespoons) and urine will be collected for routine tests, liver and kidney function tests, blood clotting tests (if needed), and tests to check the status of the disease.

If the doctor thinks the disease has either gone into remission (gotten better) or has gotten worse, you will have additional blood tests and a bone marrow biopsy to check the status of the disease.

After Month 6, during every even-numbered month you are on study (Months 8, 10, 12, and so on), blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.

Questionnaires:

You will be asked to complete a questionnaire about your symptoms and quality of life during screening, once a month for the first 6 months, and then every other month while you are on study.

You will sometimes fill out the questionnaire by hand on a piece of paper, or you may be asked the questions over the telephone by a member of the study staff. Other times, the questionnaire will be done over the phone with an automated phone system. The telephone system will ask you to rate how strong and tolerable the symptoms are, and how much the symptoms interfere with your daily life. Rating your symptoms using the telephone system should take less than 5 minutes for each call. The research nurse will teach you how to use the automated telephone system.

Length of Treatment:

You will receive the study drugs for up to 2 years. You will no longer be able to take the study drug if the doctor thinks it is in your best interest, if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions or keep appointments.

Your participation on the study will be over after the end-of-study visit.

End-of-Study Visit:

About 30 days of your last dose of study drugs:

* You will have a physical exam and neurological exam.
* Blood (about 2 tablespoons) and urine will be collected for routine tests and to check the status of the disease.
* You will have a bone marrow biopsy to check the status of the disease, if your doctor thinks it is needed.

This is an investigational study. Lenalidomide and Thalidomide are FDA approved and commercially available for the treatment of myeloma. The use of these chemotherapy drugs in treating MM that has gotten worse after treatment with lenalidomide is considered investigational. The study doctor can explain how the study drug(s) are designed to work.

Up to 17 patients will take part in this study. All will be enrolled at MD Anderson.

Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)

A Pilot Study of Thalidomide to Overcome Lenalidomide Resistance in Patients Suffering Biochemical Progression on Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:\< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to \< 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr

Thalidomide 100 mg by mouth daily for 28 days and Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.

Thalidomide + Lenalidomide

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Qaiser Bashir, MD/Associate Professor, Stem Cell Transplantation

Thalidomide 100 mg by mouth daily for 28 days; Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 day cycle.

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Irinotecan

Camptothecin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.

125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest

CPT-11

Dynamic MRI scan with dye injection through vein, every 6 weeks

MRI Scan

QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.

Quantitative Sensory Tests (QST)

Vinay K. Puduvalli, MD

Objectives:

1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.

1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.

1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.

1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.

All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.

In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.

THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.

Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.

Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme

Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.

The endpoints combined results of all strata

Patients With Recurrent Malignant Gliomas

Glioblastoma Multiforme: Thalidomide + CPT-11

Anaplastic Gliomas: Thalidomide + CPT-11

Total

Age, Categorical

Vinay Puduvalli, MD / Associate Professor

The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).

Participants With Recurrent Malignant Gliomas

7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).

Number of Participants Progression Free at 6 Months With Malignant Gliomas

Brain Stem Neoplasms

Infratentorial Neoplasms

Childhood Brain Stem Glioma

Carboplatin

Thalomid

External Beam Radiation Therapy

Stewart Goldman, MD

Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.

This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.

Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma

Ann & Robert H Lurie Children's Hospital of Chicago

Division Head

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

100 mg capsules by mouth daily each evening

20 mg/m\^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.

Donna M Weber, M.D.

Objective is to assess the activity of the combination of thalidomide and dexamethasone in patients with previously untreated multiple myeloma.

This study will examine the potential efficacy of thalidomide-dexamethasone in the treatment of patients with previously untreated multiple myeloma.

* Thalidomide is supplied as 50 mg capsules to be taken by mouth.
* Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments (according to patient tolerability) every 4 weeks.

For elderly patients, or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination, the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance. For patients who experience significant toxicity (\> grade 2) or are otherwise unable to tolerate this drug combination, the dose will be reduced by 50-100 mg decrements. For some patients with \> grade 2 toxicity, it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above.

Dexamethasone 20mg/m2 each morning after breakfast on days 1-4, 9-12, 17-20, with a repeat cycle after a 1-2 week rest period. In case of partial remission, maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects.

For patients achieving CR, consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment. No maximum trial period is planned.

At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone (CR) or daily thalidomide and dexamethasone (days 1-4) until relapse.

Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted.

In an attempt to avoid deep venous thrombosis, all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation (INR 1.5-2.5) with coumadin or therapeutic doses of low molecular weight heparin.

Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients	NCT00527657	Brain Neoplasms Melanoma	Lomustine Temozolomide Thalidomide	18 Years -	M.D. Anderson Cancer Center
Biochemotherapy With Temozolomide for Metastatic Melanoma	NCT00505635	Melanoma	Temozolomide Velban Cisplatin Interleukin-2 Intron-A Thalidomide	18 Years - 65 Years	M.D. Anderson Cancer Center
Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)	NCT01927718	Myeloma	Thalidomide Lenalidomide Questionnaires	18 Years -	M.D. Anderson Cancer Center
Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas	NCT00412542	Glioblastoma Mu... Glioma	Thalidomide CPT-11 MRI Scan Quantitative Se...	-	M.D. Anderson Cancer Center
Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma	NCT00179881	Brain Stem Neop... Neoplasms, Brai...	Carboplatin Thalomid External Beam R...	3 Years - 21 Years	Ann & Robert H Lurie Children's Hospital of Chicago
Thalidomide-Dexamethasone for Multiple Myeloma	NCT00038090	Multiple Myelom...	Thalidomide Dexamethasone	-	M.D. Anderson Cancer Center
Biochemotherapy With Temozolomide for Metastatic Melanoma	NCT00505635	Melanoma	Temozolomide Velban Cisplatin Interleukin-2 Intron-A Thalidomide	18 Years - 65 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for thalomid

Every month we try and update this database with for thalomid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for thalomid

Every month we try and update this database with for thalomid cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for thalomid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.