Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002715
• Other study ID #: IRB-13467
• Secondary ID: SUMC-G2/G3CDR000
• Status: Completed
• Phase: Phase 2
• Start date: April 1989
• Est. completion date: October 2015

Study information

• Verified date: August 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2015
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• Bleomycin sulfate
A component of the Stanford V regimen.

Drug:
• Stanford V regimen

• Doxorubicin hydrochloride
A component of the Stanford V regimen.
• Etoposide
A component of the Stanford V regimen.
• Mechlorethamine hydrochloride
A component of the Stanford V regimen.
• Prednisone
A component of the Stanford V regimen.
• Vinblastine
A component of the Stanford V regimen.
• Vincristine sulfate
A component of the Stanford V regimen.

Locations

Country	Name	City	State
United States	Stanford Cancer Center at Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation