Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal