Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
NCT ID: NCT00002715
Last Updated: 2020-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
1989-04-30
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease
NCT00002714
Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
NCT00041210
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma
NCT00086801
Combination Chemotherapy in Treating Patients With Hodgkin's Disease and HIV Infection
NCT00003262
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
NCT00079105
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Determine the feasibility of short term chemotherapy with the Stanford V regimen (mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide) followed by, as indicated, consolidative radiotherapy in patients with stage IIB, IIIA, IIIB, or IV Hodgkin's lymphoma.
* Determine the initial response to 8 weeks of Stanford V chemotherapy in these patients.
* Assess the complete and partial response rate to 12 weeks of Stanford V chemotherapy in these patients.
* Determine the acute toxicity associated with this treatment.
* Determine the disease free interval and survival following Stanford V chemotherapy with or without consolidative radiotherapy in these patients.
OUTLINE: All patients are treated on Regimen A with the Stanford V Regimen; those with initial bulky, residual, or splenic disease who achieve a CR/PR proceed to Regimen B.
* Regimen A: Patients receive mechlorethamine IV on weeks 1, 5, and 9; doxorubicin and vinblastine IV on weeks 1, 3, 5, 7, 9, and 11; vincristine and bleomycin IV on weeks 2, 4, 6, 8, 10, and 12; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and prednisone orally every other day on days 1-84. Treatment continues for 8-12 weeks, depending on response, in the absence of disease progression or unacceptable toxicity.
* Regimen B: Patients begin radiotherapy 2-4 weeks after completion of Regimen A. Patients receive radiotherapy to lungs, pleura, and other extralymphatic sites for approximately 5 weeks.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 50 patients will be entered if at least 16 of the first 22 patients respond. As of 03/96, it is expected that a total of 45 patients each with stage III/IV disease and 40 with unfavorable stage II disease will be accrued.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Combination Chemotherapy (Stanford V)
A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule
Bleomycin sulfate
A component of the Stanford V regimen.
Stanford V regimen
Doxorubicin hydrochloride
A component of the Stanford V regimen.
Etoposide
A component of the Stanford V regimen.
Mechlorethamine hydrochloride
A component of the Stanford V regimen.
Prednisone
A component of the Stanford V regimen.
Vinblastine
A component of the Stanford V regimen.
Vincristine sulfate
A component of the Stanford V regimen.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bleomycin sulfate
A component of the Stanford V regimen.
Stanford V regimen
Doxorubicin hydrochloride
A component of the Stanford V regimen.
Etoposide
A component of the Stanford V regimen.
Mechlorethamine hydrochloride
A component of the Stanford V regimen.
Prednisone
A component of the Stanford V regimen.
Vinblastine
A component of the Stanford V regimen.
Vincristine sulfate
A component of the Stanford V regimen.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed Hodgkin's lymphoma of any histology
* Unfavorable disease required
* Clinical stage IIIA, IIIB, IV, or IIB (non-bulky)
* Locally extensive stage I or II with either of the following:
* Mediastinal mass greater than 1/3 the maximum intrathoracic diameter
* Two or more extranodal sites
PATIENT CHARACTERISTICS:
Age:
* 18 to 60
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No prior malignancy except nonmelanomatous skin cancer
* No significant concurrent illness that precludes protocol participation
PRIOR CONCURRENT THERAPY:
* No prior treatment for Hodgkin's lymphoma
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sandra J. Horning, MD
Role: STUDY_CHAIR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Horning SJ, Rosenberg SA, Hoppe RT. Brief chemotherapy (Stanford V) and adjuvant radiotherapy for bulky or advanced Hodgkin's disease: an update. Ann Oncol. 1996;7 Suppl 4:105-8. doi: 10.1093/annonc/7.suppl_4.s105.
Bartlett NL, Rosenberg SA, Hoppe RT, Hancock SL, Horning SJ. Brief chemotherapy, Stanford V, and adjuvant radiotherapy for bulky or advanced-stage Hodgkin's disease: a preliminary report. J Clin Oncol. 1995 May;13(5):1080-8. doi: 10.1200/JCO.1995.13.5.1080.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUMC-G2/G3
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064551
Identifier Type: OTHER
Identifier Source: secondary_id
SQL 76234
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-H96-0806
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-13467
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.