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Completed

NCT Number: NCT00002715

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bleomycin sulfate

Biological

A component of the Stanford V regimen.

Stanford V regimen

Drug

Doxorubicin hydrochloride

Drug

A component of the Stanford V regimen.

etoposide

Drug

A component of the Stanford V regimen.

Mechlorethamine hydrochloride

Drug

A component of the Stanford V regimen.

Prednisone

Drug

A component of the Stanford V regimen.

Vinblastine

Drug

A component of the Stanford V regimen.

vincristine sulfate

Drug

A component of the Stanford V regimen.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease

Important dates

Study start
1989
Primary completion
2007
Study completion
2015
First posted
Jan 27, 2003
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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