Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Disease Progression

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Sirolimus

Diphenhydramine

Promethazine

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Pazopanib 800 mg by mouth daily. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

Temsirolimus 25 mg by vein infused over 30-60 minutes weekly. Benadryl 25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

800 mg by mouth daily in 4 week study cycle.

Pazopanib

25 mg by vein infused over 30-60 minutes every week in 4 week study cycle.

Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

Quality of Life Assessment

25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.

Benadryl

Amado Zurita, MD

The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied.

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

This is an investigational study. Pazopanib and temsirolimus are both FDA approved and commercially available for the treatment of kidney cancer. It is investigational to compare the 2 drugs.

Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

* If you are assigned to Group 1, you will take pazopanib by mouth 1 time every day at about the same time each day on an empty stomach (at least 1 hour before or 2 hours after a meal).
* If you are assigned to Group 2, you will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30 minutes before you receive each dose of temsirolimus, you will receive Benadryl (diphenhydramine) by vein over 1-2 minutes to help lower the risk of side effects.

If you are assigned to Group 1, do not crush tablets and do not repeat missed doses if it is less than 12 hours until your next scheduled dose. You will be given a pill diary to record when you take each dose. You will return the diary to the study doctor at each study visit.

If you have any side effects, you should tell the study doctor right away. If the study doctor thinks it is in your best interest, your dose may be lowered.

If the disease gets worse while you are on study, you will have the option to change to the study group you were not originally assigned to and take the other study drug. The study drug dosing and study visit schedule will be the same, and the study doctor will discuss any important details with you at the time you change study groups.

Study Visits:

Every 4 weeks on this study is called a study cycle.

Every week during Cycle 1 (Group 1 only), your blood pressure will be checked (either at home, at the clinic, or by your local doctor). If you are checking your own blood pressure at home, you will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.

Every 2 weeks for the first 2 cycles (Group 1 only) , blood (about 3 tablespoons) will be drawn for routine tests.

Every week (Group 2 only), blood (about 1 tablespoon) will be drawn for routine tests.

Every cycle (Group 2 only) OR Every other cycle (Group 1 only):

* You will have a physical exam, including measurement of your weight and vital signs.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you may have had.
* Blood (about 3 tablespoons) will be collected for routine tests.

On Day 1 of Cycle 2, Day 1 of Cycle 4, and every 4 cycles after that (Group 1 only), you will have an ECG to check your heart function.

If you are in Group 2 only, on Day 1 of Cycles 2, 3, and every other cycle after that (Cycles 5, 7, 9, and so on), blood (about 3 tablespoons) will be drawn for routine tests. You will be asked to fast (eat nothing and drink only water) for at least 8 hours before those blood draws.

Every 2 cycles:

* You will have the same imaging scans that you had at screening. After 1 year on treatment, these imaging scans may only be done every 3 cycles (Cycles 5, 8, 11, and so on).
* You will fill out the quality-of-life questionnaires.
* Blood (about 2 teaspoons) will be drawn for tests to check your thyroid function (Group 1 only).
* Urine will be collected for routine tests.

Every 4 cycles, you will have an ECG (Group 2 only).

Every 6 cycles, you will have an ECHO or MUGA scan to check your heart function.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take a study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

End-of-Treatment Follow- up:

About 30 days after you stop treatment, during a clinic visit or by phone, you will be asked about any drugs or treatments you may be receiving and any side effects you may have had.

Long-Term Follow-up:

After you stop taking the study drug, the study staff will check up on you to ask how you are doing about every 3 months from then on. The study staff will collect the information they need either from your medical records or by calling you. If you are contacted by phone, the call should only last about 5 minutes.

Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)

A Randomized Phase 2 Trial of Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma

PFS is measured from the initiation of treatment to the time of first disease progression or death due to any reason during the first drug administration in each arm. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameters of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. The PFS median of first drug pazopanib (treatment group) was compared to the PFS median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally.

Overall survival is calculated from day of therapy initiation of the first administrated drug to the date of death. Kaplan-Meier estimator used to estimate the OS for each group of participants. The Overall Survival median of first drug pazopanib (treatment group) was compared to the Overall Survival median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally.

Novartis

M.D. Anderson Cancer Center

The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.

Temsirolimus (Control Group)

Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.

Pazopanib (Treatment Group)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

100%

The KPS score measures the participant's ability to perform ordinary tasks from 100 % - 0%. 100% no signs of disease, 90% minor signs or symptoms of disease, 80% normal activity with effort, 70% cannot do normal daily activities, 60% requires occasional assistance, 50% requires considerable assistance and frequent medical care, 40% disabled requires special care, 30% severely disabled; hospital admission is indicated, 20% very sick; hospital admission needed for active supportive treatment, 10% fatal processes progressing rapidly, and 0% death.

Karnofsky Performance Status (KPS) Score

ECOG measures how how the disease impacts a participant's daily living abilities such as self-care, daily living activity, and physical ability. The scores ranges from grade 0-5: 0 fully active; 1 restricted in physically strenuous activity but can walk; 2 can walk, capable of all self-care, but cannot do any work activities; 3 capable of only limited self-care and confined to bed or chair more than 50% of waking hours; 4 completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 death.

Eastern Cooperative Oncology Group (ECOG) Performance Score

3 Factors

4 Factors

5 Factors

Participants were considered poor risk with at least 3 factors. The more risk factors the poorer the risk. The factors were any combination of an ECOG grade 2, anemia, high lactate dehydrogenase levels, high calcium levels, less than 1 year from diagnosis to the date of registration on this trial, or more than one organ with metastatic disease.

Poor -Risk With Disease Eligibility Score.

Favorable risk

Intermediate risk

Poor Risk

The IMDC score determines the overall survival in participants treated with cancer medications. The score is based on the 6 following factors: less than 1 year from time of diagnosis to trial registration, KPS score of 80% or less, anemia, high levels of calcium, high levels of neutrophils (a type of white blood cell), and a high level of platelets. The scores ranges from 0 - 6. A favorable risk score is 0. An intermediate risk score is 1 - 2. A poor risk score is 3 - 6.

International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Score

Amado J. .Zurita-Saavedra, MD/ Associate Professor, Genitourinary Medical Oncology

Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death

The ratio is comparing both arms to each other, therefore the data would be identical.

Progression Free Survival (PFS)

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death

Pazopanib 800 mg orally daily. Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death

Overall Survival (OS)

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.

First Drug Administration

Second Drug Administration

Blood and Lymph Conditions

Leukemia

Hematologic Neoplasms

Hematologic Diseases

Analgesics

Interleukin-2

Analgesics, Non-Narcotic

Interleukin-2 post-transplantation to prevent relapse of standard risk leukemia

controlled standard risk leukemia received regular transplantation without IL-2 intervention

Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Xiaojun Huang, MD

Hematopoietic stem cell transplantation (HSCT) is one of the best, and sometimes the only, option for the treatment of leukemia. However, relapse rate was still the key question to influence the overall survival after transplantation, even in standard risk leukemia.There were good evidences that natural killer cells and T regulatory cells, which were expanded and stimulated by the application of IL-2, could mediate protection against GvHD while maintaining graft anti-tumor activity as a positive side effect. Meanwhile, it was found in our previous pilot study that low-dose IL-2 subcutaneous administration from 100 days for a prolonged period could be a safe and effective strategy to prevent relapse in acute lymphoblastic malignancy patients with high risk of recurrence after unmanipulated allo-HSCT.

The study hypothesis:

Prevention of relapse using low dose IL-2 following hematopoietic stem cell transplantation in patients with standard risk acute leukemia can

* reduce relapse rate
* improve survival

Standard risk patients over 15 years old(except Ph+ ALL, AML t(8;21) and T-ALL) undergone unmanipulated blood and marrow transplantation following day 60 post-transplantation were randomized into treated group (with low dose IL-2 treatment) or controlled group (without any intervention post-transplantation). The end points were safety and clinical and immunologic response.Following time is 24 months.

Primary Outcome Measures:

\*To determine the feasibility and efficacy of administering an 6 course of subcutaneous IL-2 in this patient population. \[ Time Frame: 2 years \]

Secondary Outcome Measures:

\*To assess the immunologic impact of ultra-low dose subcutaneous IL-2 in patients after transplantation \[ Time Frame: 2 years \] Estimated Enrollment:360 Study Start Date:Jan 2012 Estimated Study Completion Date:Jan 2016

Intervention Details Description:

\*Drug: Interleukin-2 Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.

Detailed Description:

* Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
* Participants will be seen periodically while they are receiving IL-2. Physical exams and blood tests will be performed weekly for the first two weeks and then every other week until the completion of 6 course therapy.

Eligibility Ages Eligible for Study:15 Years and older Genders Eligible for Study:Both Accepts Healthy Volunteers:No Criteria

Inclusion Criteria:

* Standard risk of Recipients of allogeneic stem cell transplantation with myeloablative conditioning regimens
* Standard risk of Recipients: CR1 or CR 2 of AML/ALL before transplantation
* Ph+ ALL，AML with t(8;21) and T-ALL were excepted
* Patients were at least 60 days post-transplantation
* Bone marrow monitoring was still Complete Remission (CR) and minor residual disease (MRD) was negative
* 15 years of age or older
* No serious infection

Exclusion Criteria:

* Exposure to any other clinical trials prior to enrollment
* Active malignant disease relapse
* Active, uncontrolled infection
* Inability to comply with IL-2 treatment regimen

Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation

Low Dose of Interleukin-2 Following Allogeneic Unmanipulated Blood and Marrow Transplantation in Treating Patients With Standard Risk Hematologic Malignancy

investigate the incidences of severe GVHD and pancytopenia after IL-2 application to evaluate the safety of this drug.

observe the drug toxicity based on common toxicity criteria (CTC,version 3.0). compare the relapse rate and incidence of positive MRD between two groups to evaluate the efficiency of IL-2 application.

examine the immune reconstitution of subgroups of T cells after IL-2 application and compare with that of controlled group of patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)	NCT01392183	Kidney Cancer	Pazopanib Temsirolimus Quality of Life... Benadryl	18 Years -	M.D. Anderson Cancer Center
Efficiency Study of Low Dose of IL-2 to Prevent Relapse in Standard Risk Leukemia After Transplantation	NCT01517347	Leukemia	Interleukin-2	15 Years - 65 Years	Peking University People's Hospital
Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)	NCT01392183	Kidney Cancer	Pazopanib Temsirolimus Quality of Life... Benadryl	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cr

Every month we try and update this database with for cr 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 cr

Every month we try and update this database with for cr 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 cr 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.