Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

PEG-Intron

Razelle Kurzrock, M.D.

The purpose of this study is to determine if PEG-Intron is better tolerated and more efficacious than standard interferons (Roferon, Intron) in patients with Philadelphia-positive Chronic Myelogenous Leukemia. These patients should have previously received standard interferon therapy and have been intolerant, resistant, or have relapsed disease.

It has been shown that patients who experience complete hematologic or at least a partial cytogenetic response to interferon will have improved survival times. In addition, evidence exists that even patients who do not demonstrate a cytogenetic response to interferon treatment can still benefit from treatment, in terms of survival, compared to patients not treated with interferon. This indicates that if a patient is better able to tolerate interferon, he or she may have improved survival even without cytogenetic response. Preliminary studies suggest that PEG-Intron is more convenient for patients (administered once weekly rather than daily), is better tolerated than interferon, and can produce hematologic remission in interferon-a resistant patients. Phase II studies are needed to ascertain the overall hematologic and cytogenetic response rates to PEG-Intron in such patients.

PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron

A Phase II Study of SCH 54031 (Peg Interferon Alpha-2B/PEG-Intron) in Subjects With Interferon-Refractory Chronic Myelogenous Leukemia

Schering-Plough

M.D. Anderson Cancer Center

Immune System Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Leukemia, Lymphoid

Influenza, Human

Leukemia, Lymphocytic, Chronic, B-Cell

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Lymphocytic Leukemia

Vaccines

Peginterferon alfa-2a

TIV (Influenza Vaccine Trivalent Inactivated) alone

15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.

Influenza Vaccine Trivalent Inactivated (TIV)

180 μg (0.5 ml) before receiving TIV, through a needle under the skin.

Pegylated interferon (PEGrIFN-α, Pegasys)

3 million units (0.5 ml) before receiving TIV, through a needle under the skin.

Interferon (IFNα, Roferon-A)

Amar Safdar, MD

The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).

The Study Drugs:

Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.

TIV is designed to prevent the flu.

Screening Test:

Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need to be drawn. Women who are able to have children must have a negative blood (about 1 teaspoon) blood test within 2 weeks of study entry.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups.

If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2, you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will receive interferon with TIV.

You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the study doctor, study staff, and you will know which group you are in.

Study Drug Administration:

You will receive TIV through a needle into a muscle in your arm (the arm you do not write with) on Days 1 and 28.

* If you are in Group 1, you will only receive TIV
* If you are in Group 2, you will receive pegylated interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
* If you are in Group 3, you will receive interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.

After you are given the injection(s), you will be watched for 15 minutes in the clinic before you are allowed to go home.

You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any symptoms you may be experiencing, and you will also record your body temperature.

Study Visits:

On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to the flu virus.

On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will be reviewed. If you cannot come to the clinic, a member of the research staff will call you to review this information. This phone call will take 15-30 minutes.

On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to the flu virus.

On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit, you may have your blood drawn at a local clinic. You will then mail the blood to the study doctor in a pre-paid envelope.

On Month 6, you will be called and asked about any side effects you may have experienced. This phone call will take 15-30 minutes.

Length of Study:

You will be considered off study after the Month 6 phone call. You will be taken off-study early if intolerable side effects or an allergic reaction occurs.

This is an investigational study. TIV, pegylated interferon, and interferon are FDA approved and commercially available. At this time, the use of pegylated interferon and standard interferon with TIV is only being used for research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia

Skin and Connective Tissue Diseases

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Etoposide

Etoposide phosphate

Enzyme Inhibitors

Interferon Alpha 5x10\^6 mu/m\^2 subcutaneously and Etoposide 100 mg/m\^2 intravenously, both daily for 5 days

100 mg/m\^2 Intravenous Daily for 5 days, beginning one hour after IFN-alpha treatment.

5x10\^6 mu/m\^2 Subcutaneously Daily for 5 Days

Interferon Alpha

Eugenie S. Kleinerman, MD

Primary Objectives:

1. To determine the efficacy of combining Interferon Alpha (IFN) with etoposide for the treatment of relapsed osteosarcoma.
2. To determine if IFN alters the plasma pharmacokinetics of etoposide.
3. To determine the toxicities of IFN and etoposide when administered together.
4. To determine IFN blood levels following combination therapy.

Interferon Alpha (IFN)- will be given as a shot under the skin. One hour later, VP-16 will be infused through a catheter (tube) placed in a vein over 3 hours. The drugs will be given daily for 5 days. The treatment will be repeated every 3 - 4 weeks for up to 24 - 32 weeks (8 courses). The catheter will remain in place throughout treatment.

Patients who are candidates for surgery will first receive two courses of treatment. If the tumor gets worse or if severe side effects occur, treatment will be stopped, and the tumor will be removed right away. If the tumor responds well (begins to shrink or does not get worse) and severe side effects do not occur, the patient will receive six more courses of treatment after surgery.

Patients who are not candidates for surgery will receive two initial courses of treatment. If the tumor responds well and severe side effects do not occur, the patient will receive six more courses of treatment.

The treatment will be given in the outpatient department. Before treatment begins, the patient will have a health examination. Blood tests, a urine test, and heart tests will be given. X-rays, computed tomography (CT) scans, and a bone scan will be done. The location and size of all lesions will be recorded.

During treatment, patients will have a blood test every week. Before each course, a health examination, a urine test, and chest x-ray will be given and the size of all measurable cancer will be recorded. After the second course, the CT and bone scans will be repeated. All the tests will be repeated at the end of the study.

About 37 patients will be treated on the study at M. D. Anderson.

THIS IS AN INVESTIGATIONAL STUDY. IFN- and VP-16 are approved by the U.S. Food and Drug Administration for treating some types of cancer. Their use together against osteosarcoma is investigational.

Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma

Phase II Study of Recombinant Interferon Alpha and Etoposide in Patients With Relapsed Osteosarcoma

Complete Response (CR): Disappearance of all evidence of tumor for at least one cycle; Lytic or mixed bone lesions improved by scan or shown some ossification by x-ray; and free of all symptoms of cancer. Partial Response (PR): 50% or \> decrease in sum of product of diameters of all measured lesions persisting for at least one cycle or 4 weeks. No lesion may increase in size or new lesion appear. Minor Response (MR): Decrease in measurable lesion(s) too small or too brief to qualify as Partial Response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PEG-Intron For Chronic Myelogenous Leukemia Patients Unresponsive To Or Intolerant Of Roferon Or Intron	NCT00037882	Leukemia, Myelo...	PEG-Intron	-	M.D. Anderson Cancer Center
Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia	NCT00962715	Chronic Lymphoc...	Influenza Vacci... Pegylated inter... Interferon (IFN...	18 Years -	M.D. Anderson Cancer Center
Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma	NCT00504140	Osteosarcoma	Etoposide Interferon Alph...	5 Years - 70 Years	M.D. Anderson Cancer Center
Recombinant Interferon Alpha and Etoposide in Relapsed Osteosarcoma	NCT00504140	Osteosarcoma	Etoposide Interferon Alph...	5 Years - 70 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for roferon

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

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