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CompletedNCT00002715Updated Aug 12, 2020

Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

A Phase 2 interventional study of Bleomycin sulfate and Stanford V regimen in Lymphoma, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by Stanford University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 years 7 months after the study started (first participant enrolled Apr 1989, registered Nov 1999).
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Lymphoma

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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
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Combination Chemotherapy (Stanford V)

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

    Biological: Bleomycin sulfate · Drug: Stanford V regimen · Drug: Doxorubicin hydrochloride · Drug: Etoposide · Drug: Mechlorethamine hydrochloride · Drug: Prednisone · Drug: Vinblastine · Drug: Vincristine sulfate

Interventions

  • BiologicalBleomycin sulfate

    A component of the Stanford V regimen.

  • DrugStanford V regimen
  • DrugDoxorubicin hydrochloride

    A component of the Stanford V regimen.

  • DrugEtoposide

    A component of the Stanford V regimen.

  • DrugMechlorethamine hydrochloride

    A component of the Stanford V regimen.

  • DrugPrednisone

    A component of the Stanford V regimen.

  • DrugVinblastine

    A component of the Stanford V regimen.

  • DrugVincristine sulfate

    A component of the Stanford V regimen.

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Study locations

1 site
  • Stanford Cancer Center at Stanford University Medical Center
    Stanford, California 94305, United States
07

References and documents

Publications

  • 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. PubMed 8836420 ↗
  • 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. PubMed 7537796 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002715
Lead sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 1989
Primary completion
Jan 2007
Completion
Oct 2015
Last update
Aug 12, 2020

Study contacts

Sandra J. Horning, MD
study chair · Stanford University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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