Suspended

A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkin's Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkin's Disease

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What is being tested

bleomycin sulfate

+ dacarbazine

+ doxorubicin hydrochloride

BiologicalDrugProcedure
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

From 15 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2000
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 24, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2000

Actual date on which the first participant was enrolled.

OBJECTIVES: Compare progression-free and overall survival of patients with stage III or IV Hodgkin's disease treated with doxorubicin, bleomycin, vinblastine, and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy. Compare the toxic effects of these treatment regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of poor prognostic factors (3 vs 4 vs 5) and stage of disease (III vs IV). Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes, bleomycin IV over 10 minutes, vinblastine IV over 5 minutes, and dacarbazine IV over 15-30 minutes on days 1 and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms. Arm I: Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses. Arm II: Patients receive 1 additional course of induction chemotherapy followed by stem cell collection. Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV on day -2. Patients undergo autologous peripheral blood stem cell transplantation on day 0. Patients are followed at 60 days, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 460 patients will be accrued for this study within 4 years.

NCT00005090
Principal SponsorSWOG Cancer Research Network
Last updated: January 24, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV Hodgkin's disease with at least 3 of the following characteristics: Albumin less than 4.0 mg/dL Hemoglobin less than 10.5 g/dL Leukocytosis at least 15,000/mm^3 Lymphocytopenia less than 600/mm^3 or less than 8% of total WBC Male sex At least 45 years of age Stage IV disease Bidimensionally measurable disease Bilateral or unilateral bone marrow aspiration and biopsy performed within 42 days of study Negative chest x-ray within 42 days of study OR Chest x-ray performed within 28 days of study Negative CT scan of thorax, abdomen, and pelvis within 42 days of study OR CT scan of thorax, abdomen, and pelvis performed within 28 days of study No history of lymphoma, myelodyplastic syndrome, or leukemia No CNS involvement by Hodgkin's disease PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless elevation due to liver infiltration by Hodgkin's disease) Lymphoma-related hepatic dysfunction allowed Renal: Creatinine no greater than 2.0 times ULN Creatinine clearance at least 60 mL/min Lymphoma-related renal dysfunction allowed Cardiovascular: No coronary artery disease, cardiomyopathy, congestive heart failure, or arrhythmias requiring therapy Ejection fraction normal No significant EKG abnormalities suggesting active cardiac disease Pulmonary: Corrected DLCO at least 60% OR FEV1 at least 60% predicted Other: Not pregnant or nursing Fertile patients must use effective contraception No HIV or AIDS No other prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer No active bacterial, fungal, or viral infection* Afebrile for 3 consecutive days* NOTE: *Prior to randomization portion of study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for Hodgkin's disease except single course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) within 35 days of study Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for Hodgkin's disease Surgery: Not specified Other: At least 3 days since prior antibiotics, antifungals, or antivirals (except for prophylactic therapy or fever associated with underlying lymphoma) (for randomization portion of study)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m^2, bleomycin 10 U/m^2, vinblastine 6 mg/m^2, dacarbazine 375 mg/m^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant.

Group II

Experimental
Patients receive 5 28-day cycles of ABVD (doxorubicin 25 mg/m^2, bleomycin 10 U/m^2, vinblastine 6 mg/m^2, dacarbazine 375 mg/m^2 all on days 1 and 15). Patients with no disease progression are then randomized to either 3 more cycles of ABVD or 1 more cycle of ABVD + high-dose therapy + stem cell transplant. Patients randomized to the transplant arm have 2 x 10^6 CD34+ blood mononuclear cells/kg of actual body weight collected at day -7. High dose therapy consists of BCNU 150/m^2 on days -6 to -4, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Peripheral blood stem cells are infused on day 0.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 47 locations

Veterans Affairs Medical Center - Birmingham

Birmingham, United StatesOpen Veterans Affairs Medical Center - Birmingham in Google Maps

University of California San Diego Cancer Center

La Jolla, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, United States

UCSF Cancer Center and Cancer Research Institute

San Francisco, United States
Suspended47 Study Centers