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Mitoguazone

Enzyme Inhibitors

To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).

Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.

A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma

Phase II Evaluation of Mitoguazone Dihydrochloride in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma Associated With Acquired Immunodeficiency Syndrome

Genzyme, a Sanofi Company

Hodgkin Disease

Hodgkin Lymphoma

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Neuroprotective Agents

Gemcitabine

Bleomycin

Dexamethasone

Etoposide

Vinorelbine

Cytarabine

Doxorubicin

Liposomal doxorubicin

Vincristine

Melphalan

Cisplatin

Prednisolone

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Methylprednisolone

Dacarbazine

Carmustine

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Vindesine

Isophosphamide mustard

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Antibiotics, Antitubercular

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Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Protective Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients receive ABVD and VABEM chemotherapy.

Patients receive VABEM, CEO, BEAM, and MINE chemotherapy. Patients also undergo allogeneic or autologous stem cell transplantation.

bleomycin sulfate

ABVD regimen

carmustine

cisplatin

cytarabine

dacarbazine

dexamethasone

doxorubicin hydrochloride

etoposide

gemcitabine hydrochloride

ifosfamide

melphalan

methylprednisolone

mitoguazone

vincristine sulfate

vindesine

vinorelbine tartrate

Patients undergo allogeneic stem cell transplantation

allogeneic hematopoietic stem cell transplantation

Patients undergo autologous stem cell transplantation

autologous hematopoietic stem cell transplantation

Delphine Senecal

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.

PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.

OBJECTIVES:

Primary

* Evaluate event-free survival.

Secondary

* Evaluate overall survival.
* Evaluate the prognostic value of FDG-PET scanning.
* Evaluate progression-free survival.
* Evaluate tolerability.
* Evaluate rate of relapse.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups according to prognosis.

* Group 1 (favorable prognosis): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin sulfate IV, vincristine sulfate IV, dacarbazine IV, and methylprednisolone IV on days 1 and 14. Treatment repeats every 28 days for 2 courses. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

  * Favorable response: Patients with favorable response receive 1 additional course of ABVD chemotherapy.
  * Unfavorable response: Patients with unfavorable response receive 1 course of VABEM chemotherapy comprising vindesine IV continuously on days 1-5, doxorubicin hydrochloride IV continuously on days 1-3, carmustine IV on day 3, etoposide IV on days 3-5, and methylprednisolone IV on days 1-5.
* Group 2 (intermediate prognosis): Patients receive 2 courses of ABVD chemotherapy. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

  * Favorable response: Patients with favorable response receive 4 additional courses of ABVD chemotherapy.
  * Unfavorable response: Patients with unfavorable response receive VABEM chemotherapy. Treatment with VABEM chemotherapy repeats every 28 days for 2 courses.
* Group 3 (poor prognosis): Patients receive 2 courses of VABEM chemotherapy. Patients then undergo PET scan for evaluation of response. Patients receive additional treatment according to response.

  * Favorable response: Patients with favorable response receive 1 additional course of VABEM chemotherapy.
  * Unfavorable response: Patients with unfavorable response receive CEO chemotherapy comprising cisplatin IV continuously on days 1-3, gemcitabine hydrochloride IV on days 1 and 8, and oral dexamethasone once daily on days 1-4. Treatment repeats every 21 days for 3 courses. Patients then undergo PET scan. Patients receive additional treatment according to response.

    * Favorable response: Patients with favorable response receive BEAM chemotherapy comprising carmustine IV on day -7, etoposide IV and cytarabine IV on days -6 to -3, and melphalan IV on day -2. Patients then undergo autologous stem cell transplantation on day 0.
    * Unfavorable response: Patients with unfavorable response receive MINE chemotherapy comprising mitoguazone IV, vinorelbine ditartrate IV, and ifosfamide IV on days 1-5 and etoposide IV on days 1-3. Treatment repeats every 28 days for 3 courses. Patients then undergo allogeneic or autologous stem cell transplantation.

Patients with favorable response or a "bulky" mass at diagnosis may also undergo radiotherapy.

After completion of study treatment, patients are followed periodically for 15 years.

Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma

French Innovative Leukemia Organisation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma	NCT00002348	Lymphoma, Non-H... HIV Infections	Mitoguazone	18 Years -	Sanofi
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma	NCT00002348	Lymphoma, Non-H... HIV Infections	Mitoguazone	18 Years -	Sanofi
Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma	NCT00920153	Lymphoma	bleomycin sulfa... ABVD regimen carmustine cisplatin cytarabine dacarbazine dexamethasone doxorubicin hyd... etoposide gemcitabine hyd... ifosfamide melphalan methylprednisol... mitoguazone vincristine sul... vindesine vinorelbine tar... allogeneic hema... autologous hema...	18 Years - 65 Years	French Innovative Leukemia Organisation

Spots Global Cancer Trial Database for mitoguazone

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

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