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Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma - Article


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Mechlorethamine

Mustargen



Clinical Trial: Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Stanford University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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:

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

Study chairs or principal investigators

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.

Study ID Numbers:  CDR0000064551; SUMC-G2/G3; NCI-H96-0806
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

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November 18, 2008



Page Updated: June 1, 2005
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