Mechlorethamine |
Mustargen |
Clinical Trial: Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
This study is no longer recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult Hodgkin's lymphoma | Drug: bleomycin Drug: doxorubicin Drug: etoposide Drug: mechlorethamine Drug: prednisone Drug: vinblastine Drug: vincristine Procedure: chemotherapy | Phase II |
MedlinePlus related topics: Hodgkin's Disease
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Pilot Study of the Stanford V Regimen in Patients With Stage IIB, IIIA, IIIB, or IV Hodgkin's Lymphoma
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.
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
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
Location Information
California
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305, United States
Sandra J. Horning, MD, Study Chair, Stanford University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
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.
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. Review.
Record last reviewed: June 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002715
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Mechlorethamine (Drug Digest)
- Mustargen (Drug Digest)

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