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A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A PHASE II PILOT STUDY OF SHORT TERM (12 WEEK) COMBINATION CHEMOTHERAPY (STANFORD V) IN UNFAVORABLE HODGKIN'S DISEASE


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000064551

NCT ID:

NCT00002715

Start Date:

April 1989

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305