Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Bleomycin

Doxorubicin

Liposomal doxorubicin

Vinblastine

Dacarbazine

Interferons

Interferon-alpha

Interferon alpha-2

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antiviral Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tubulin Modulators

Antimitotic Agents

Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)

4 (x106 IU/m\^2) subcutaneously on days 1-4.

Interferon-2A

Adriamycin

Velban

Anas Younes, MD

This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN.

Each treatment cycle will last 2 weeks. On days 1 - 4 of each cycle, patients will be given a shot of IFN under the skin. On day 4, patients will be given ABVD through a vein over one-hour.

The plan is for patients to receive 12 cycles of treatment. However, patients will leave the study if they have severe side effects or if the cancer grows or spreads. They will also leave if the cancer does not improve after 6 cycles. Patient who leave the study will be offered other treatments. A maximum of 35 patients will be treated with that dose.

Before the first treatment, patient will have a physical exam, blood tests, and a heart scan. Within 1 month of starting treatment, patients will have a chest X-ray, CT scans of the abdomen and pelvis, and a gallium scan.

During the study, patient will have blood tests every week and a physical exam every 2 weeks. The X-ray, CT scans, and gallium scan will be repeated after cycles 6 and 12.

All the drugs in this study are approved by the U.S. Food and Drug Administration and are available by prescription. ABVD is a standard treatment for Hodgkin's disease; IFN is an investigational treatment for Hodgkin's disease. About 35 patients will be enrolled in the study. All treatment will be given in the outpatient clinic at M.D. Anderson Cancer Center.

Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease

A Phase II Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) for Patients With Hodgkin's Disease

Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: \> 25 % increase in size of any measurable lesion or appearance of significant new lesions.

Schering-Plough

M.D. Anderson Cancer Center

Interferon-2A + Chemotherapy

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Anas Younes, MD / Professor

Complete Response

Uncomfirmed Complete Response

Partial Response

Progressive Disease

Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.

Participants' Response

Overall Study

Skin and Connective Tissue Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Analgesics

Temozolomide

Aldesleukin

Cisplatin

Thalidomide

Interleukin-2

Analgesics, Non-Narcotic

Immunosuppressive Agents

Angiogenesis Inhibitors

Growth Inhibitors

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

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

Nicholas E. Papadopoulos, MD

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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease	NCT01404936	Lymphoma	Interferon-2A Adriamycin Bleomycin Velban Dacarbazine	-	M.D. Anderson Cancer Center
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease	NCT01404936	Lymphoma	Interferon-2A Adriamycin Bleomycin Velban Dacarbazine	-	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
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 velban

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

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