Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: Bleomycin sulfate
* Drug: Stanford V regimen
* Drug: Doxorubicin hydrochloride
* Drug: Etoposide
* Drug: Mechlorethamine hydrochloride
* Drug: Prednisone
* Drug: Vinblastine
* Drug: Vincristine sulfate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Chemotherapy (Stanford V)<br>A combination chemotherapy regimen consisting of mechlorethamine, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide and prednisone, administered on a compressed schedule | Biological: Bleomycin sulfate<br>* A component of the Stanford V regimen.<br>Drug: Stanford V regimen<br> <br> Drug: Doxorubicin hydrochloride<br>* A component of the Stanford V regimen.<br>Drug: Etoposide<br>* A component of the Stanford V regimen.<br>Drug: Mechlorethamine hydrochloride<br>* A component of the Stanford V regimen.<br>Drug: Prednisone<br>* A component of the Stanford V regimen.<br>Drug: Vinblastine<br>* A component of the Stanford V regimen.<br>Drug: Vincristine sulfate<br>* A component of the Stanford V regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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