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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bleomycin sulfate
Stanford V regimen
Doxorubicin hydrochloride
Etoposide
Mechlorethamine hydrochloride
Prednisone
Vinblastine
Vincristine sulfate
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Stage I adult Hodgkin lymphoma, Stage II adult Hodgkin lymphoma, Stage III adult Hodgkin lymphoma, Stage IV adult Hodgkin lymphoma, Adult lymphocyte predominant Hodgkin lymphoma, Adult lymphocyte depletion Hodgkin lymphoma, Adult nodular sclerosis Hodgkin lymphoma, Adult mixed cellularity Hodgkin lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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

Sites / Locations

  • Stanford Cancer Center at Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Chemotherapy (Stanford V)

Arm Description

A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 10, 2020
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002715
Brief Title
Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
Official Title
A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 1989 (Actual)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Stage I adult Hodgkin lymphoma, Stage II adult Hodgkin lymphoma, Stage III adult Hodgkin lymphoma, Stage IV adult Hodgkin lymphoma, Adult lymphocyte predominant Hodgkin lymphoma, Adult lymphocyte depletion Hodgkin lymphoma, Adult nodular sclerosis Hodgkin lymphoma, Adult mixed cellularity Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination Chemotherapy (Stanford V)
Arm Type
Experimental
Arm Description
A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule
Intervention Type
Biological
Intervention Name(s)
Bleomycin sulfate
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Stanford V regimen
Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Mechlorethamine hydrochloride
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
A component of the Stanford V regimen.
Intervention Type
Drug
Intervention Name(s)
Vincristine sulfate
Intervention Description
A component of the Stanford V regimen.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra J. Horning, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford Cancer Center at Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8836420
Citation
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.
Results Reference
result
PubMed Identifier
7537796
Citation
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.
Results Reference
result

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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

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