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

Antirheumatic Agents

Rituximab

Vincristine

Antineoplastic Agents, Immunological

Rituximab 375 mg/m\^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m\^2 IV, Bleomycin 10 U/m\^2 IV, Vinblastine 6 mg/m\^2 IV, DTIC 375 mg/m\^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.

375 mg/m\^2 by vein over 3 to 8 hours weekly for 6 weeks in a row.

25 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

10 U/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

6 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

375 mg/m\^2 injected by vein over 3 hours every other week for a total of 12 treatments.

Dacarbazine (DTIC)

Primary Objective:

- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Rituximab and ABVD for Hodgkin's Patients

A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease

Five year Event Free Survival (EFS) is proportion of surviving participants who remain event free out of total participants at 5 years after receiving Rituximab + ABVD (RABVD). Event-free Survival (EFS) analyzed every 6 months.

Genentech, Inc.

Rituximab + ABVD Chemotherapy

5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD

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
Rituximab and ABVD for Hodgkin's Patients	NCT00504504	Lymphoma	Rituximab Adriamycin Bleomycin Vinblastine Dacarbazine (DT...	16 Years -	M.D. Anderson Cancer Center
Rituximab and ABVD for Hodgkin's Patients	NCT00504504	Lymphoma	Rituximab Adriamycin Bleomycin Vinblastine Dacarbazine (DT...	16 Years -	M.D. Anderson Cancer Center
Rituximab and ABVD for Hodgkin's Patients	NCT00504504	Lymphoma	Rituximab Adriamycin Bleomycin Vinblastine Dacarbazine (DT...	16 Years -	M.D. Anderson Cancer Center
Rituximab and ABVD for Hodgkin's Patients	NCT00504504	Lymphoma	Rituximab Adriamycin Bleomycin Vinblastine Dacarbazine (DT...	16 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for blm

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

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